FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM
MDR report key: 14839994
·
Received June 28, 2022
Report
- Report Number
- 3005180920-2022-00499
- Event Type
- Injury
- Date Received
- June 28, 2022
- Date of Event
- June 2, 2022
- Report Date
- June 28, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030818295
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 103790: 49 ITEMS MANUFACTURED AND RELEASED ON 31-JAN-2011. EXPIRATION DATE: 2015-12-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 45 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 10 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE INSERT IMPLANTING A THICKER ONE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704354 | GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 5 / 12 MM | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.07.0512FUC | 103790 | 07630030818295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |