FDA Adverse Event Injury Summary report: N

PERSONA CR FEMORAL COMPONENT

MDR report key: 4112877 · Received September 17, 2014

Report

Report Number
3007963827-2014-00043
Event Type
Injury
Date Received
September 17, 2014
Date of Event
August 19, 2014
Report Date
August 19, 2014
Manufacturer
ZIMMER ORTHOPEDIC MFG LTD
Product Code
JWH
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
PHYSICIAN

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 PATIENT WAS NOT ACHIEVING FLEXION GOALS AND UNDERWENT MANIPULATION UNDER ANESTHESIA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
576047 PERSONA CR FEMORAL COMPONENT JWH ZIMMER ORTHOPEDIC MFG LTD 62477593

Patients

Seq Age Sex Outcome Treatment
1 59 YR Other