FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM
MDR report key: 8762587
·
Received July 4, 2019
Report
- Report Number
- 3005180920-2019-00530
- Event Type
- Injury
- Date Received
- July 4, 2019
- Date of Event
- June 4, 2019
- Report Date
- July 4, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030816659
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 14 JUN 2019: LOT 132867: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2013. EXPIRATION DATE: 2018-07-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED AFTER 4 YEARS AND 3 MONTHS AFTER THE PRIMARY DUE TO INSTABILITY CAUSED BY KNEE LAXITY. THE SURGEON PERFORMED A LINER SWAP (SIZE 14MM HAS BEEN EXCHANGED WITH 20 MM) AND RESURFACED THE PATELLA. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 556298 | GMK-PRIMARY TIBIAL INSERT UC FIXED SIZE 2 / 14 MM | KNEE FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 132867 | 07630030816659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |