FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L E-CROSS
MDR report key: 17348642
·
Received July 19, 2023
Report
- Report Number
- 3005180920-2023-00519
- Event Type
- Injury
- Date Received
- July 19, 2023
- Date of Event
- June 16, 2023
- Report Date
- July 19, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971261990
- PMA / PMN Number
- K202022
- 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 2240499: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-DEC-2022. EXPIRATION DATE: 2027-11-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37405 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L E-CROSS | KNEE TIBIAL INSERT E-CROSS | JWH | MEDACTA INTERNATIONAL SA | 02.12.E0510FL | 2240499 | 07630971261990 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |