FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM
MDR report key: 11593955
·
Received March 31, 2021
Report
- Report Number
- 3005180920-2021-00246
- Event Type
- Injury
- Date Received
- March 31, 2021
- Date of Event
- March 2, 2021
- Report Date
- March 31, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817755
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12.03.2021: LOT 183192: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2018. EXPIRATION DATE: 2023-06-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
1 MONTH AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED AN I&D AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PREVIOUSLY THE PATIENT HAD IMPLANTED COMPETITOR IMPLANTS, AND ON (B)(6) 2021 MEDACTA IMPLANTS WERE IMPLANTED DUE TO UNKNOWN REASON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 491908 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 4/12MM | TIBIAL INSERT FIXED | JWH | MEDACTA INTERNATIONAL SA | 02.07.0412SCF | 183192 | 07630030817755 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |