FDA Adverse Event
Injury
Summary report: N
CARTIVA
MDR report key: 13606555
·
Received February 25, 2022
Report
- Report Number
- 3009351194-2022-00031
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- October 26, 2018
- Report Date
- January 15, 2021
- Manufacturer
- CARTIVA
- Product Code
- PNW
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT WAS RETURNED FOR REVIEW. MORE DETAILS CAN BE FOUND IN THE ATTACHED REPORT. ON NOVEMBER 10TH, 2020 STRYKER TRAUMA AND EXTREMITIES ACQUIRED CARTIVA, WRIGHT MEDICAL, TORNIER INC. AND TORNIER SAS. AN EFFORT WAS MADE TO ALIGN THE ACQUIRED ENTITY COMPLAINT FILES WITH STRYKER'S POLICIES AND PROCEDURES. STRYKER HAS PERFORMED RETROSPECTIVE REVIEW OF COMPLAINTS AND THE REPORTABILITY DECISION WAS REVISED TO REPORT THIS INCIDENT UNDER THE MDR/VIGILANCE PROCESS.
Description of Event or Problem · 0
"FEEDBACK RECEIVED FROM (B)(6) IPA SALES REP: "IMPLANT SHRUNK IN MET (MTP) HEAD. PATCHED WITH MTF BONE AND IMPLANTED ANOTHER (CARTIVA) UNIT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2407359 | CARTIVA | PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT | PNW | CARTIVA | CAR-10 | F051117001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Other |