FDA Adverse Event
Injury
Summary report: N
GMK-HINGE 02.09.2603L FEMORAL COMPONENT #3 L
MDR report key: 12517862
·
Received September 23, 2021
Report
- Report Number
- 3005180920-2021-00757
- Event Type
- Injury
- Date Received
- September 23, 2021
- Date of Event
- August 24, 2021
- Report Date
- September 23, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KRO
- UDI-DI
- 07630030825439
- 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 26 AUGUST 2021 LOT 172032: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-JUNE-2017. EXPIRATION DATE: 2022-MAY-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMUR AND THE CAUSE OF THE LOOSE FEMUR IS UNKNOWN. 2 YEARS AND 10 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE FEMORAL COMPONENT AND POLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1417069 | GMK-HINGE 02.09.2603L FEMORAL COMPONENT #3 L | FEMORAL COMPONENT | KRO | MEDACTA INTERNATIONAL SA | 02.09.2603L | 172032 | 07630030825439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |