FDA Adverse Event
Malfunction
Summary report: N
KLASSIC TIBIAL BASEPLATE FOR PRIMARY OR REVISION
MDR report key: 13634924
·
Received March 1, 2022
Report
- Report Number
- 3008544874-2022-00004
- Event Type
- Malfunction
- Date Received
- March 1, 2022
- Date of Event
- December 29, 2021
- Report Date
- January 4, 2022
- Manufacturer
- TOTAL JOINT ORTHOPEDICS, INC.
- Product Code
- JWH
- PMA / PMN Number
- K162256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
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 TIBIAL BASEPLATE 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 |
|---|---|---|---|---|---|---|---|
| 2235275 | KLASSIC TIBIAL BASEPLATE FOR PRIMARY OR REVISION | TIBIAL BASEPLATE | JWH | TOTAL JOINT ORTHOPEDICS, INC. | 190513-9 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |