FDA Adverse Event Injury Summary report: N

PERSONA PEGGED POROUS TIBIAL PLATE

MDR report key: 4252913 · Received November 12, 2014

Report

Report Number
1822565-2014-01576
Event Type
Injury
Date Received
November 12, 2014
Report Date
October 14, 2014
Manufacturer
ZIMMER, INC.
Product Code
OIY
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
NC, 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 SURGEON HAS OBSERVED RADIOLUCENCY ON ONE POST OP X-RAYS FOR THIS PT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
728986 PERSONA PEGGED POROUS TIBIAL PLATE OIY ZIMMER, INC. 62331234

Patients

Seq Age Sex Outcome Treatment
1 Other