FDA Adverse Event
Injury
Summary report: N
GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2
MDR report key: 12874309
·
Received November 25, 2021
Report
- Report Number
- 3005180920-2021-00915
- Event Type
- Injury
- Date Received
- November 25, 2021
- Date of Event
- October 27, 2021
- Report Date
- November 25, 2021
- 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 29 OCTOBER 2021. LOT 150872: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JULY-2015. EXPIRATION DATE: 2020-MAY-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
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 6 YEARS AND 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE PATELLA AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1773696 | GMK-PRIMARY 02.07.0034RP PATELLA RESURFACING SIZE 2 | KNEE PATELLA | JWH | MEDACTA INTERNATIONAL SA | 02.07.0034RP | 150872 | 07630030815751 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Other |