FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L
MDR report key: 17659802
·
Received August 31, 2023
Report
- Report Number
- 3005180920-2023-00657
- Event Type
- Injury
- Date Received
- August 31, 2023
- Date of Event
- August 3, 2023
- Report Date
- August 31, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826733
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 07 AUGUST 2023: LOT 2010601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2020. EXPIRATION DATE: 2025-10-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
REVISION SURGERY AT ABOUT 2 YEARS AND 4 MONTHS POST PRIMARY FOR INFECTION. THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1602341 | GMK-SPHERE 02.12.0510FL TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L | KNEE TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 2010601 | 07630030826733 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | Required Intervention |