FDA Adverse Event
Injury
Summary report: N
GMK-HINGE FIXED TIBIAL INSERT SIZE 3/17MM
MDR report key: 8826042
·
Received July 25, 2019
Report
- Report Number
- 3005180920-2019-00602
- Event Type
- Injury
- Date Received
- July 25, 2019
- Date of Event
- June 25, 2019
- Report Date
- July 25, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KRO
- UDI-DI
- 07630030825149
- 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 10 JULY 2019: LOT 181582: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2018 EXPIRATION DATE: 2023-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND A REVISION OF THE POLY (PRIMARY SURGERY WAS PERFORMED 1 MONTH EARLIER). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 620028 | GMK-HINGE FIXED TIBIAL INSERT SIZE 3/17MM | KNEE TIBIAL INSERT | KRO | MEDACTA INTERNATIONAL SA | 181582 | 07630030825149 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |