FDA Adverse Event
Injury
Summary report: N
GMK-HINGE 02.09.0214H FIXED TIBIAL INSERT SIZE 2/14MM
MDR report key: 8319911
·
Received February 8, 2019
Report
- Report Number
- 3005180920-2019-00044
- Event Type
- Injury
- Date Received
- February 8, 2019
- Date of Event
- January 11, 2019
- Report Date
- February 8, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KRO
- UDI-DI
- 07630030825064
- PMA / PMN Number
- K130299
- 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 181574: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JUNE 2018. EXPIRATION DATE: 2023-06-11. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT KNEE FOR INFECTION. I&D AND INSERT SWAP PERFORMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113756 | GMK-HINGE 02.09.0214H FIXED TIBIAL INSERT SIZE 2/14MM | KNEE TIBIAL INSERT | KRO | MEDACTA INTERNATIONAL SA | 181574 | 07630030825064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |