FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L
MDR report key: 18957392
·
Received March 22, 2024
Report
- Report Number
- 3005180920-2024-00130
- Event Type
- Injury
- Date Received
- March 22, 2024
- Date of Event
- February 22, 2024
- Report Date
- March 22, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826771
- 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 28 FEB 2024: LOT 2002758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2020. EXPIRATION DATE: 2025-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT 3 YEARS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND 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 |
|---|---|---|---|---|---|---|---|
| 2275872 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2002758 | 07630030826771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |