FDA Adverse Event
Malfunction
Summary report: N
MBT TIB IMPACTOR REPLACE PARTS
MDR report key: 8228443
·
Received January 8, 2019
Report
- Report Number
- 1818910-2019-80221
- Event Type
- Malfunction
- Date Received
- January 8, 2019
- Date of Event
- December 11, 2018
- Report Date
- December 11, 2018
- Manufacturer
- DEPUY ORTHOPAEDICS INC US
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EXAMINATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED SCRATCHED CONDITION. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9505-01-559 LOT 082138 WAS SCRATCHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21253 | MBT TIB IMPACTOR REPLACE PARTS | KNEE INSTRUMENT : IMPACTORS | JWH | DEPUY ORTHOPAEDICS INC US | 082138 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |