FDA Adverse Event
Injury
Summary report: N
GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM
MDR report key: 9144400
·
Received October 2, 2019
Report
- Report Number
- 3005180920-2019-00834
- Event Type
- Injury
- Date Received
- October 2, 2019
- Date of Event
- September 12, 2019
- Report Date
- October 2, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817175
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(4) 2019: LOT 183190: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-JUL-2018. EXPIRATION DATE: 2023-07-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ON THE 3 SEPTEMBER 2019 WE WERE INFORMED OF A REVISION SURGERY PERFORMED ON THE (B)(6) 2019, 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO STIFFNESS OF THE KNEE. THE SURGEON PERFORMED A LINER SWAP (SIZE 12 MM TO 10 MM) SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 942491 | GMK-REVISION FIXED TIBIAL INSERT SC SIZE 3/12MM | KNEE TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 183190 | 07630030817175 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |