FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE PATELLA RESURFACING SIZE 2
MDR report key: 7868585
·
Received September 12, 2018
Report
- Report Number
- 3005180920-2018-00669
- Event Type
- Injury
- Date Received
- September 12, 2018
- Date of Event
- August 13, 2018
- Report Date
- September 12, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030815751
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 SEPTEMBER 2018; LOT 180309: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 MAY 2018. EXPIRATION DATE: 2023-04-25; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED DUE TO PATELLA DISLOCATION AFTER ABOUT 1 MONTH FROM THE PRIMARY. THE SURGEON REVISED THE PATELLA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712209 | GMK-SPHERE PATELLA RESURFACING SIZE 2 | PATELLA RESURFACING | JWH | MEDACTA INTERNATIONAL SA | 180309 | 07630030815751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |