FDA Adverse Event
Injury
Summary report: N
GMK-REVISION 02.07.0314SCF FIXED TIBIAL INSERT SC SIZE 3/14MM
MDR report key: 8310184
·
Received February 6, 2019
Report
- Report Number
- 3005180920-2019-00023
- Event Type
- Injury
- Date Received
- February 6, 2019
- Date of Event
- January 7, 2019
- Report Date
- February 6, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030817298
- 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 05 FEBRUARY 2019: LOT 172162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-OCT-2017. EXPIRATION DATE: 2022-10-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ABOUT 6 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR LAXITY. LINER SWAP. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102714 | GMK-REVISION 02.07.0314SCF FIXED TIBIAL INSERT SC SIZE 3/14MM | FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 172162 | 07630030817298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |