FDA Adverse Event
Injury
Summary report: N
CARTIVA IMPLANT
MDR report key: 13606077
·
Received February 25, 2022
Report
- Report Number
- 3009351194-2022-00056
- Event Type
- Injury
- Date Received
- February 25, 2022
- Date of Event
- May 2, 2019
- Report Date
- August 6, 2019
- Manufacturer
- CARTIVA, INC
- Product Code
- PNW
- PMA / PMN Number
- P150017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. ON NOVEMBER 10ST, 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
IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE. ALLEGEDLY, THE PATIENT HAS LOST SPACE IN THE JOINT AND HAS PAIN, REVISION WILL BE NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2407337 | CARTIVA IMPLANT | PROSTHESIS, METATARSOPHALANGEAL JOINT CARTILAGE REPLACEMENT IMPLANT | PNW | CARTIVA, INC | CAR-10-US | F080918001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |