FDA Adverse Event
Injury
Summary report: N
GMK SPHERE TOTAL KNEE SYSTEM
MDR report key: 23850111
·
Received December 19, 2025
Report
- Report Number
- 3005180920-2025-01300
- Event Type
- Injury
- Date Received
- December 19, 2025
- Date of Event
- December 8, 2025
- Report Date
- December 19, 2025
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030862625
- PMA / PMN Number
- K140826
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 19 DECEMBER 2025. LOT 1902502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JUNE-2019. EXPIRATION DATE: 2024-05-12. 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. ROOT CAUSE: THE SURGEON REVISED LINER HEIGHT, WHICH IS A COMMON PRACTICE TO RESTORE THE JOINT STABILITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT.
Description of Event or Problem · 0
AT ABOUT 6 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING LAXITY AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE LINER TO GIVE THE PATIENT MORE STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2386467 | GMK SPHERE TOTAL KNEE SYSTEM | GMK-SPHERE TIBIAL INSERT - FLEX S4R - 11 MM | JWH | MEDACTA INTERNATIONAL SA | 02.12.0411FR | 1902502 | 07630030862625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |