FDA Adverse Event
Injury
Summary report: N
GMK-REVISION 02.07.0517SCF FIXED TIBIAL INSERT SC SIZE 5/17MM
MDR report key: 16722679
·
Received April 12, 2023
Report
- Report Number
- 3005180920-2023-00240
- Event Type
- Injury
- Date Received
- April 12, 2023
- Date of Event
- March 14, 2023
- Report Date
- April 12, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JWH
- UDI-DI
- 07630030818578
- PMA / PMN Number
- K103170
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 21 MARCH 2023: LOT 2200931: (B)(4) MANUFACTURED AND RELEASED ON 28-MAR-2022. EXPIRATION DATE: 2027-03-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN WAS UNKNOWN. AT 2 MONTHS POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND POLY SWAP AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1348883 | GMK-REVISION 02.07.0517SCF FIXED TIBIAL INSERT SC SIZE 5/17MM | KNEE FIXED TIBIAL INSERT | JWH | MEDACTA INTERNATIONAL SA | 02.07.0517SCF | 2200931 | 07630030818578 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |