FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R
MDR report key: 18146681
·
Received November 16, 2023
Report
- Report Number
- 3005180920-2023-00894
- Event Type
- Injury
- Date Received
- November 16, 2023
- Date of Event
- October 18, 2023
- Report Date
- November 16, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819896
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 23 OCTOBER 2023 LOT 1904228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-OCT-2019. EXPIRATION DATE: 2024-09-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 3 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THE SURGEON OBSERVED THAT THE PATIENT HAD ONLY 80-90 DEGREES OF FLEXION AND THE SURGEON CONCLUDED THAT THE TIBIA WAS NOT CUT WITH ENOUGH POSTERIOR SLOPE. THE SURGEON PERFORMED A NEW CUT TO CORRECT THE SLOPE (3 TO 6 +/- 1 DEGREE) AND REVISED THE INSERT AND TIBIA. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2238684 | GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 R | KNEE CEMENTED TIBIAL TRAY | JWH | MEDACTA INTERNATIONAL SA | 1904228 | 07630030819896 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |