FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE PATELLA RESURFACING SIZE 2
MDR report key: 14942802
·
Received July 7, 2022
Report
- Report Number
- 3005180920-2022-00524
- Event Type
- Injury
- Date Received
- July 7, 2022
- Date of Event
- June 22, 2022
- Report Date
- July 7, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030815751
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 28-JUN-2022. LOT 2118421: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAR-2022. EXPIRATION DATE: 2027-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AFTER THE PRIMARY SURGERY, IT WAS DISCOVERED THE PATELLA DISLOCATION FROM THE FEMUR. AT ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED ALL THE IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1257573 | GMK-SPHERE PATELLA RESURFACING SIZE 2 | PATELLA RESURFACING | JWH | MEDACTA INTERNATIONAL SA | 02.07.0034RP | 2118421 | 07630030815751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |