FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM R
MDR report key: 17413826
·
Received July 28, 2023
Report
- Report Number
- 3005180920-2023-00579
- Event Type
- Injury
- Date Received
- July 28, 2023
- Date of Event
- July 7, 2023
- Report Date
- July 28, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630040707480
- PMA / PMN Number
- K181635
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023: LOT 2119301: 50 ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2022. EXPIRATION DATE: 2027-02-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 39 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY AT ABOUT 9 MONTHS POST PRIMARY DUE TO INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2320740 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/10 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2119301 | 07630040707480 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |