FDA Adverse Event
Malfunction
Summary report: N
KLASSIC® FEMUR WITH COBALT 3D, SIZE 6
MDR report key: 13635011
·
Received March 1, 2022
Report
- Report Number
- 3008544874-2022-00003
- Event Type
- Malfunction
- Date Received
- March 1, 2022
- Date of Event
- November 17, 2021
- Report Date
- February 23, 2022
- Manufacturer
- TOTAL JOINT ORTHOPEDICS, INC.
- Product Code
- MBH
- UDI-DI
- 00814703016752
- PMA / PMN Number
- K162256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED IN A TOTAL KNEE ARTHROPLASTY CASE, UPON OPENING AND INSPECTION OF THE PACKAGING PER THE IFU, IT WAS NOTICED THAT THE INNER PACKAGING OF A KNEE FEMUR WAS DAMAGED, THE IMPLANT WAS NOT OPENED OR USED IN SURGERY. A SECOND IDENTICAL IMPLANT WAS INSPECTED AND OPENED WITHOUT REPORT OF ISSUE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, THERE WAS NO IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1940564 | KLASSIC® FEMUR WITH COBALT 3D, SIZE 6 | KNEE FEMUR | MBH | TOTAL JOINT ORTHOPEDICS, INC. | 5106.06.000 | Q210415-7 | 00814703016752 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |