FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE PATELLA RESURFACING SIZE 4
MDR report key: 16502651
·
Received March 8, 2023
Report
- Report Number
- 3005180920-2023-00117
- Event Type
- Injury
- Date Received
- March 8, 2023
- Date of Event
- February 7, 2023
- Report Date
- March 8, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030815775
- PMA / PMN Number
- K113571
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2000634: 330 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: 2025-02-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 320 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 2 YEARS 7 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO PATELLAR IMPLANT SUBLUXATION. WIDENING OF THE PATELLAR TENDON POSSIBLY FOLLOWING PROGRESSIVE TEARING OF THE INTERNAL PARAPATELLAR ATHROTOMY. NO LOOSENING OF THE IMPLANTS, NO INFECTION, NO TRAUMA. THE SURGEON REVISED SUCCESSFULLY THE PATELLA IMPLANT (SAME SIZE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164136 | GMK-SPHERE PATELLA RESURFACING SIZE 4 | KNEE PATELLAR IMPLANT | JWH | MEDACTA INTERNATIONAL SA | 02.07.0036RP | 2000634 | 07630030815775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | Required Intervention |