FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R
MDR report key: 15037411
·
Received July 18, 2022
Report
- Report Number
- 3005180920-2022-00553
- Event Type
- Injury
- Date Received
- July 18, 2022
- Date of Event
- June 28, 2022
- Report Date
- July 18, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826580
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 05 JULY 2022: LOT 2002795: 75 ITEMS MANUFACTURED AND RELEASED ON 10-JUNE-2020. EXPIRATION DATE: 2025-06-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 62 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY FOR KNEE INSTABILITY. THE SURGEON EXPLANTED THE LINER THICK 12MM AND IMPLANTED A THICKER LINER OF 17MM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2872623 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/12 MM R | KNEE TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.12.0412FR | 2002795 | 07630030826580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention |