FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM
MDR report key: 18901162
·
Received March 14, 2024
Report
- Report Number
- 3005180920-2024-00121
- Event Type
- Injury
- Date Received
- March 14, 2024
- Date of Event
- February 14, 2024
- Report Date
- March 14, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817410
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2024. LOT 2001349: 18 ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2020. EXPIRATION DATE: 2025-03-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 8 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT HAD STIFFNESS IN THE KNEE AND THE CAUSE IS UNKNOWN. AT ABOUT 2 YEARS AND 11 MONTHS POST PRIMARY THE SURGEON REVISED THE SEMICONSTRAINED LINER AND IMPLANTED A POSTERO-STABILIZED LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1969428 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/17MM | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2001349 | 07630030817410 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |