FDA Adverse Event Summary report: N

STRYKER ACETABULAR DOME HOLE PLUG

MDR report key: 2931792 · Received December 27, 2012

Report

Report Number
2931792
Date Received
December 27, 2012
Date of Event
July 23, 2012
Report Date
December 27, 2012
Manufacturer
STRYKER
Product Code
KWB
Report Source
User Facility report
Reporter Location
UT, US

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED WITH AN INFECTED RIGHT TOTAL HIP REPLACEMENT FROM 2010. THE PROSTHESIS WAS EXPLANTED. NOT A MALFUNCTION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STRYKER ACETABULAR DOME HOLE PLUG PROSTHESIS, HIP, ACETABULAR COMPONENT KWB STRYKER * 1JK0D0
2 STRYKER TRITANIUM PROSTHESIS, HIP, HEMISPHERICAL CLUSTER HOLE SHELL LPH STRYKER * 502-03-56E
3 STRYKER TRIDENT PROSTHESIS, HIP, POLYETHYLENE INSERT LZO STRYKER C3 0* POLYETHYLENE INSERT 623-0040E
4 REJUVENATE PROSTHESIS, HIP, MODULAR NECK MEH STRYKER NLV-340880Y *
5 STRYKER TORX PROSTHESIS, HIP, CANCELLOUS BONE SCREW HRS STRYKER * MJMY05
6 STRYKER TORX PROSTHESIS, HIP, CANCELLOUS BONE SCREW HRS STRYKER * MJLJDT
7 REJUVENATE SPT MODULAR STEM PROSTHESIS, HIP, MODULAR STEM MEH STRYKER * MJD7K1
8 STRYKER LFIT ANATOMIC V40 PROSTHESIS, HIP, FEMORAL HEAD LZO STRYKER * MJL5H0

Patients

Seq Age Sex Outcome Treatment
1 72 YR