FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS
MDR report key: 19297226
·
Received May 13, 2024
Report
- Report Number
- 3005180920-2024-00290
- Event Type
- Injury
- Date Received
- May 13, 2024
- Date of Event
- April 15, 2024
- Report Date
- May 13, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971261754
- PMA / PMN Number
- K202022
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 19-APR-2024: LOT 2247366: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-MAR-2023. EXPIRATION DATE: 2028-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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. AT ABOUT 8 MONTHS AFTER PRIMARY, THE SURGEON REVISED THE INSERT (10MM) WITH A THICKER ONE (13MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 858774 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 4/10 MM L E-CROSS | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 2247366 | 07630971261754 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention |