FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R
MDR report key: 16435300
·
Received February 24, 2023
Report
- Report Number
- 3005180920-2023-00100
- Event Type
- Injury
- Date Received
- February 24, 2023
- Date of Event
- January 30, 2022
- Report Date
- February 24, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826740
- 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 6 FEBRUARY 2023: LOT 2112474: (B)(4) MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-OCT-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY AND THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE INSERT (FROM 10MM TO 17MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1935354 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0510FR | 2112474 | 07630030826740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |