FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L
MDR report key: 15959145
·
Received December 12, 2022
Report
- Report Number
- 3005180920-2022-00935
- Event Type
- Injury
- Date Received
- December 12, 2022
- Date of Event
- November 23, 2022
- Report Date
- December 12, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826337
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 30-NOV-2022: LOT 2000392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-MAR-2020. EXPIRATION DATE: 2025-02-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 2 YEARS AND 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER (10MM) TO A THICKER ONE (12MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 386098 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0310FL | 2000392 | 07630030826337 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |