FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
MDR report key: 16520693
·
Received March 10, 2023
Report
- Report Number
- 3005180920-2023-00137
- Event Type
- Injury
- Date Received
- March 10, 2023
- Date of Event
- February 8, 2023
- Report Date
- March 10, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826740
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 15-FEB-2023. LOT 2217062: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-SEP-2022. EXPIRATION DATE: 2027-08-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE POLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1148822 | GMK-SPHERE 02.12.0510FR TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R | KNEE TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0510FR | 2217062 | 07630030826740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |