FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R
MDR report key: 14239391
·
Received April 28, 2022
Report
- Report Number
- 3005180920-2022-00298
- Event Type
- Injury
- Date Received
- April 28, 2022
- Date of Event
- March 29, 2022
- Report Date
- April 28, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030825804
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 01 APRIL 2022. LOT 2000481:(B)(4) EXPIRATION DATE: 2025-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). OTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 01 APRIL 2022 GMK-SPHERE 02.07.1203R TIBIAL TRAY FIXED CEMENTED # 3 R (K090988) LOT 2005689: (B)(4). EXPIRATION DATE: 2025-09-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4). GMK-SPHERE 02.07.0035RP PATELLA RESURFACING # 3 (K0909889 LOT 2006037: (B)(4). EXPIRATION DATE: 2025-07-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. (B)(4).
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN DUE TO ASEPTIC LOOSENING OF TIBIA, FEMUR, AND PATELLA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS 10 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105809 | GMK-SPHERE 02.12.0002R FEMORAL COMPONENT SPHERE CEMENTED SIZE 2 R | FEMORAL COMPONENT CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0002R | 2000481 | 07630030825804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |