FDA Adverse Event
Malfunction
Summary report: N
PERSONA CR ARTICULAR SURFACE
MDR report key: 3162379
·
Received June 6, 2013
Report
- Report Number
- 1822565-2013-00929
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 8, 2013
- Report Date
- May 8, 2013
- Manufacturer
- ZIMEMR INC
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DOCTOR TRIED LOCKING IN THE POLY IN THE TIBIA, BUT THE POLY WOULD NOT LOCK IN. ANOTHER POLY WAS OPENED AND IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251316 | PERSONA CR ARTICULAR SURFACE | JWH | ZIMEMR INC | 62177282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |