FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R E-CROSS
MDR report key: 16664348
·
Received April 3, 2023
Report
- Report Number
- 3005180920-2023-00226
- Event Type
- Injury
- Date Received
- April 3, 2023
- Date of Event
- March 5, 2023
- Report Date
- April 3, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630971262089
- 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 17-MAR-2023. LOT 2212160: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-AUG-2022. EXPIRATION DATE: 2027-07-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 1 MONTH AND 1 WEEK AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1116122 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/12 MM R E-CROSS | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.E0512FR | 2212160 | 07630971262089 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |