FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
MDR report key: 17904253
·
Received October 10, 2023
Report
- Report Number
- 3005180920-2023-00769
- Event Type
- Injury
- Date Received
- October 10, 2023
- Date of Event
- September 16, 2023
- Report Date
- October 10, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826535
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 18 SEPTEMBER 2023. LOT 2112454: 75 ITEMS MANUFACTURED AND RELEASED ON 11-OCT-2021. EXPIRATION DATE: 2026-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 74 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 1 YEAR AND 8 MONTHS FROM THE PRIMARY, KNEE REVISION SURGERY ON THE LEFT SIDE DUE TO INFECTION. NO LOOSENING OF THE IMPLANTS. EXPLANTATION OF THE TIBIAL INSERT AND REIMPLANTATION OF A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 347644 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2112454 | 07630030826535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |