FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
MDR report key: 17763774
·
Received September 18, 2023
Report
- Report Number
- 3005180920-2023-00736
- Event Type
- Injury
- Date Received
- September 18, 2023
- Date of Event
- August 29, 2023
- Report Date
- September 18, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819896
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 01-SEPT-2023. LOT 2303900: 24 ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2023. EXPIRATION DATE: 2028-05-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 1 MONTH FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIA LOOSENING. NO KNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289922 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R | KNEE TIBIAL TRAY | JWH | MEDACTA INTERNATIONAL SA | 2303900 | 07630030819896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention |