FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L
MDR report key: 17379535
·
Received July 24, 2023
Report
- Report Number
- 3005180920-2023-00550
- Event Type
- Injury
- Date Received
- July 24, 2023
- Date of Event
- June 28, 2023
- Report Date
- July 24, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826535
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 05 JULY 2023: LOT 2205558: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUNE-2022. EXPIRATION DATE: 2027-05-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 20 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 FOR INFECTION AT 6 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATHOGEN IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1370119 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2205558 | 07630030826535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |