FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY PATELLA RESURFACING SIZE 1
MDR report key: 8133919
·
Received December 5, 2018
Report
- Report Number
- 3005180920-2018-00965
- Event Type
- Injury
- Date Received
- December 5, 2018
- Date of Event
- October 26, 2017
- Report Date
- November 6, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030815737
- 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 (B)(6) 2018: LOT 173021: 130 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2017. EXPIRATION DATE: (B)(6) 2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 118 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN DUE TO INSTABILITY CAUSED BY A LOOSE PATELLA IMPLANT AFTER ABOUT ONE YEAR FROM PRIMARY SURGERY. THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 973983 | GMK-PRIMARY PATELLA RESURFACING SIZE 1 | PATELLA RESURFACING | JWH | MEDACTA INTERNATIONAL SA | 173021 | 07630030815737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |