FDA Adverse Event Injury Summary report: N

PINNACLE CUP

MDR report key: 2132691 · Received June 10, 2011

Report

Report Number
MW5021004
Event Type
Injury
Date Received
June 10, 2011
Date of Event
June 2, 2011
Report Date
June 10, 2011
Manufacturer
DEPUY
Product Code
KWA
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

REMOVAL OF A DEPUY PINNACLE CUP, LINER, AND SUMMIT STEM 3 YEARS AFTER IMPLANTATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PINNACLE CUP CUP KWA DEPUY
2 PINNACLE LINER LINER KWA DEPUY
3 PINNACLE SUMMIT STEM STEM LPH DEPUY

Patients

Seq Age Sex Outcome Treatment
1 68 YR Hospitalization