FDA Adverse Event
Malfunction
Summary report: N
PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM
MDR report key: 5761538
·
Received June 30, 2016
Report
- Report Number
- 0001822565-2016-02244
- Event Type
- Malfunction
- Date Received
- June 30, 2016
- Report Date
- January 19, 2017
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- PMA / PMN Number
- PK113369
- Removal / Correction Number
- Z-1052-2015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE. PRODUCT RECEIVED BUT NOT YET EVALUATED.
Additional Manufacturer Narrative · 1
PREVIOUS INVESTIGATION FOUND THAT SONIC CLEANING MAY BE A CONTRIBUTING FACTOR TO THE EJECTING OF THE BALL AND SPRING FROM THE PERSONA TASP SHIMS, AND THAT A USER NEED OF THE DEVICE TO BE ABLE TO WITHSTAND ULTRASONIC CLEANING WAS NOT IDENTIFIED DURING DEVELOPMENT. ZIMMER INITIATED A FIELD ACTION ON (B)(6) 2014. THE INSTRUMENT WAS MANUFACTURED BEFORE THE RECALL WAS LAUNCHED AND BEFORE ANY RE-DESIGN WAS IMPLEMENTED. AS SUCH, A PREVIOUSLY ADDRESSED DESIGN ISSUE IS CONSIDERED AS THE ROOT CAUSE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE BALL BEARINGS ARE MISSING FROM THE PROVISIONAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416162 | PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM | KNEE PROVISIONAL | JWH | ZIMMER, INC. | 62806914 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |