FDA Adverse Event
Injury
Summary report: N
GMK SPHERE TOTAL KNEE SYSTEM
MDR report key: 21503353
·
Received March 3, 2025
Report
- Report Number
- 3005180920-2025-00149
- Event Type
- Injury
- Date Received
- March 3, 2025
- Date of Event
- February 6, 2025
- Report Date
- March 3, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971262003
- PMA / PMN Number
- K202022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 14 FEBRUARY 2024: LOT 2421790: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-SEP-2024. EXPIRATION DATE: 2029-09-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 1 WEEK AFTER 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 |
|---|---|---|---|---|---|---|---|
| 1330648 | GMK SPHERE TOTAL KNEE SYSTEM | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R E-CROSS | JWH | MEDACTA INTERNATIONAL SA | 02.12.E0510FR | 2421790 | 07630971262003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Required Intervention |