FDA Adverse Event
Malfunction
Summary report: N
CARTIVA
MDR report key: 13606440
·
Received February 25, 2022
Report
- Report Number
- 3009351194-2022-00079
- Event Type
- Malfunction
- Date Received
- February 25, 2022
- Report Date
- January 22, 2021
- Manufacturer
- CARTIVA
- Product Code
- PNW
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE PRODUCT WAS NOT RETURNED NOR WERE IMAGES PROVIDED FOR REVIEW; THEREFORE, PRODUCT ANALYSIS CANNOT BE PERFORMED. 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 AS PART OF (B)(6) PATIENT SURVEY. PATIENT REPORTED HIS CARTIVA IMPLANT AS A "FAILURE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146905 | CARTIVA | PROSTESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT | PNW | CARTIVA | CARTIVA SCI | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |