FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L
MDR report key: 16807318
·
Received April 25, 2023
Report
- Report Number
- 3005180920-2023-00303
- Event Type
- Injury
- Date Received
- April 25, 2023
- Date of Event
- March 29, 2023
- Report Date
- April 25, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030819926
- PMA / PMN Number
- K121416
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023:LOT 2112443: 120 ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2021. EXPIRATION DATE: 2026-NOV-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 74 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER (FROM 12MM TO 17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 562584 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/12 MM L | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.07.1205L | 2112443 | 07630030819926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Female | Required Intervention |