FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2
MDR report key: 15121612
·
Received July 28, 2022
Report
- Report Number
- 3005180920-2022-00570
- Event Type
- Injury
- Date Received
- July 28, 2022
- Date of Event
- July 5, 2022
- Report Date
- July 28, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030815751
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 11 JULY 2022: LOT 2000627: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAR-2020. EXPIRATION DATE: 2025-02-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE PATELLA AND THE CAUSE OF THE LOOSE PATELLA IS UNKNOWN. AT ABOUT 2 YEARS FORM PRIMARY THE SURGEON REVISED THE PATELLA AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2286196 | GMK-SPHERE 02.07.0034RP PATELLA RESURFACING SIZE 2 | KNEE PATELLA RESURFACING | JWH | MEDACTA INTERNATIONAL SA | 02.07.0034RP | 2000627 | 07630030815751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |