FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L
MDR report key: 14250749
·
Received April 29, 2022
Report
- Report Number
- 3005180920-2022-00312
- Event Type
- Injury
- Date Received
- April 29, 2022
- Date of Event
- March 31, 2022
- Report Date
- April 29, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819902
- PMA / PMN Number
- K090988
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2022. LOT 2102507: (B)(6) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2021. EXPIRATION DATE: 2026-05-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(6) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
SUBSIDENCE OF THE EXTERNAL TIBIAL TRAY FOR AN UNKNOWN REASON. ALL IMPLANTS WERE REVISED 1 MONTH AND A HALF AFTER PRIMARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 119166 | GMK-SPHERE 02.07.1204L TIBIAL TRAY FIXED CEMENTED SIZE 4 L | TIBIAL TRAY FIXED CEMENTED | JWH | MEDACTA INTERNATIONAL SA | 02.07.1204L | 2102507 | 07630030819902 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention |