FDA Adverse Event Injury Summary report: N

ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM LOCKING SCREW

MDR report key: 722596 · Received June 2, 2006

Report

Report Number
1822565-2006-00135
Event Type
Injury
Date Received
June 2, 2006
Date of Event
April 22, 2006
Report Date
May 2, 2006
Manufacturer
ZIMMER, INC.
Product Code
HWC
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE DEVICES WERE IMPLANTED IN 2006. ON APRIL 22, 2006, POST-OP X-RAY SHOWED THE LOCKING SCREWS APPEARED TO BE BROKEN AT THE PLATE/SCREW SHAFT INTERFACE. THE DEVICES WERE REVISED IN 2006.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM LOCKING SCREW PERIARTICULAR SCREW HWC ZIMMER, INC. NA 60344727

Patients

Seq Age Sex Outcome Treatment
1 62 YR Hospitalization| R