FDA Adverse Event
Injury
Summary report: N
GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R
MDR report key: 16596966
·
Received March 23, 2023
Report
- Report Number
- 3005180920-2023-00176
- Event Type
- Injury
- Date Received
- March 23, 2023
- Date of Event
- February 24, 2023
- Report Date
- March 23, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030826344
- 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 03-MAR-2023: LOT: 2212748: (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 WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN REPORTING PAIN DUE TO A WOUND DEHISCENCE AFTER ABOUT 3 WEEKS FROM THE PRIMARY. THE SURGEON PERFORMED A WASHOUT AND POLY SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 479954 | GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 3/10 MM R | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.12.0310FR | 2212748 | 07630030826344 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |