FDA Adverse Event Injury Summary report: N

STRYKER ORTHOPAEDICS

MDR report key: 544887 · Received September 16, 2004

Report

Report Number
544887
Event Type
Injury
Date Received
September 16, 2004
Date of Event
June 28, 2004
Report Date
September 13, 2004
Manufacturer
STRYKER ORTHOPAEDICS
Product Code
KWB
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

FAILED ACETABULUM PT HAD TOTAL HIP 3 MONTHS PREVIOUSLY. ACETABULUM SLIPPED INTO VALGIS CAUSING PAIN AFTER HIP SUBLUXED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STRYKER ORTHOPAEDICS ACETABULAR SHELL, INSERT, SCREWS KWB STRYKER ORTHOPAEDICS 542-11-54F *

Patients

Seq Age Sex Outcome Treatment
1 76 YR Hospitalization #'S ON STICKER, ID#10000027MP