FDA Adverse Event
Injury
Summary report: N
GMK-HINGE FIXED TIBIAL INSERT SIZE 6/12MM
MDR report key: 14370925
·
Received May 12, 2022
Report
- Report Number
- 3005180920-2022-00372
- Event Type
- Injury
- Date Received
- May 12, 2022
- Date of Event
- April 14, 2022
- Report Date
- May 12, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KRO
- UDI-DI
- 07630030825330
- PMA / PMN Number
- K130299
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 21 APRIL 2022: LOT 173997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-SEPT-2017. EXPIRATION DATE: 2022-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT SINCE 2018.
Description of Event or Problem · 0
THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 YEARS AND 1 MONTH POST PRIMARY THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 956078 | GMK-HINGE FIXED TIBIAL INSERT SIZE 6/12MM | KNEE REVISION TIBIAL INSERT | KRO | MEDACTA INTERNATIONAL SA | 02.09.0612H | 173997 | 07630030825330 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |