FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L
MDR report key: 14207481
·
Received April 26, 2022
Report
- Report Number
- 3005180920-2022-00309
- Event Type
- Injury
- Date Received
- April 26, 2022
- Date of Event
- March 30, 2022
- Report Date
- April 26, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030825811
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2000467: 97 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2020. EXPIRATION DATE: (B)(6) 2025. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 96 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
REVISION SURGERY PERFORMED DUE TO THE FEMORAL ROTATION WHICH LEFT THE PATIENT IN VALGUS. THE SURGEON REVISED THE FEMORAL COMPONENT AND INSERT (1 YEAR AND 6 MONTHS AFTER THE PRIMARY), THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1592129 | GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 3 L | KNEE FEMORAL COMPONENT CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0003L | 2000467 | 07630030825811 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |