- MicroPort Orthopedics Inc.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Ave.|
Silver Spring, MD 20993-0002
June 17, 2015
VIA UNITED PARCEL SERVICE
Vice President, Regulatory Affairs
Microport Orthopedics, Inc.
5677 Airline Rd
Arlington, TN 38002
Dear Mr. Anas:
This Warning Letter is to inform you of your firm’s failure to comply with requirements under section 522 of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. § 360, and 21 CFR Part 822. Through postmarket surveillance study order PS110070, dated May 6, 2011, the Food and Drug Administration (FDA) ordered Wright Medical Technology, Inc. (Wright Medical), former proprietor of MicroPort Orthopedics, Inc. (MicroPort), to conduct postmarket surveillance for the devices listed below:
K004043 – Metal Transcend Articulation System
K021349 – Metal Transcend Articulation System (Larger Sizes)
K031963 – Conserve Plus Spiked Acetabular Shells And Conserve Total 56mm Femoral Head
K041114 – Profemur Tapered Hip Stem
K041425 – Conserve Plus Revision Shell And Conserve Plus Thick Shell
K041586 – Profemur S Hip Stem
K042530 – Conserve Plus HA Acetabular Shells
K043073 – Procotyl-E Acetabular System
K043099 – Lineage HA Acetabular Shells
K051348 – Conserve Total Femoral Head
K051995 – Profemur Renaissance Hip Stem
K052915 – Profemur XTR Hip Stem
K053588 – Profemur LX Hip Stem
K060356 – Conserve Plus Quadrafix Acetabular Shell
K060358 – Profemur TL Hip Stem
K061844 – Dynasty Porous Acetabular Shell and COCR Acetabular Liner
K070785 – Dynasty Acetabular System
K080663 – Profemur LX Revision 5/8 Coated Hip Stem
K081090 – Profemur LX 5/8 Coated Hip Stem
K082924 – Dynasty Porous Acetabular Shell, Dynasty Polyethylene Acetabular Liner, Dynasty Metal Acetabular Liner
K091423 – Profemur Hip System Modular Necks
K110029 – Conserve Onserve Bio Foam Shell
The final postmarket surveillance plan for these devices, PS110070/A007, was approved on November 1, 2012. However, Wright Medical failed to enroll clinical sites or patients in the subsequent year.
On January 9, 2014, MicroPort acquired the devices subject to the 522 order from Wright Medical. On April 8, 2014, FDA notified you that all previous regulatory requirements remain in effect and are now the responsibility of MicroPort.
During a teleconference on May 13, 2014, FDA informed your firm that Wright Medical had committed to a protocol and that MicroPort was expected to follow the approved study plan. Two weeks later, on May 27, 2014, MicroPort requested an exemption from the 522 order. FDA denied the exemption request on July 25, 2014.
Your firm’s representative sent a protocol synopsis (b)(4) to us on September 25, 2014. FDA listed the deficiencies with this proposal and rejected it in the not approvable letter dated November 24, 2014. On December 30, 2014, your firm submitted a revised protocol synopsis (b)(4) and on April 5, 2015 FDA received your firm’s study plan (b)(4). Your April 2015 study plan is not approved for the reasons specified in our not approvable letter dated June 16, 2015. You failed to revise your postmarket surveillance submission to address the concerns specified in the not approvable letter of November 24, 2014. The submissions received by FDA have not addressed all of the questions listed in the 522 order. MicroPort is expected to take every action possible to complete an approved study plan without further delay. MicroPort is expected to begin the study within 60 days of the plan approval date, or to initiate the currently approved study within 45 days of receipt of this letter.
Failure or refusal of a manufacturer to comply with a requirement under section 522, which includes requirements specified under 21 CFR Part 822, is a prohibited act under section 301(q)(1)(C) of the Act, 21 U.S.C. § 331(q)(1)(C). Further, your Metal-on-Metal Hip System devices are misbranded under section 502(t)(3) of the Act, 21 U.S.C. § 352(t)(3), in that your firm failed or refused to comply with a requirement under section 522 of the Act. Specifically, MicroPort has failed to design an approvable plan that will answer the questions in the order, or to conduct surveillance in accordance with the previously-approved plans. 21 CFR §§ 822.11 and 822.20.
Your firm should take prompt action to correct this violation. Failure to promptly correct this violation may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Please note that Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
If corrective action cannot be completed within 15 calendar days, notify this office in writing of the reason for the delay and the time within which the corrections will be completed.
Your study plan and response to this letter should be sent to:
522 Postmarket Surveillance Studies Program
Food and Drug Administration
Center for Devices and Radiological Health
10903 New Hampshire Avenue
Building 66, Room 4278
Silver Spring, Maryland 20993-0002.
If you have any questions about the content of this letter please contact:
Krista Flores, Consumer Safety Officer
CDRH, Office of Compliance
Division of Bioresearch Monitoring
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of postmarket surveillance reporting requirements for your device and does not necessarily address other obligations you have under the law.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and