FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R
MDR report key: 18272888
·
Received December 6, 2023
Report
- Report Number
- 3005180920-2023-00929
- Event Type
- Injury
- Date Received
- December 6, 2023
- Date of Event
- November 9, 2023
- Report Date
- December 6, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862625
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 13 NOVEMBER 2023. LOT 1905129: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-AUG-2019. EXPIRATION DATE: 2024-JUL-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
ABOUT 3 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO INFECTION. WASH-OUT PERFORMED AND LINER REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2160386 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/11 MM R | KNEE TIBIAL INSERT POLYETHYLENE | JWH | MEDACTA INTERNATIONAL SA | 1905129 | 07630030862625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |