FDA Adverse Event Malfunction Summary report: N

GLENOID-DE PUY

MDR report key: 173777 · Received June 15, 1998

Report

Report Number
MW1014042
Event Type
Malfunction
Date Received
June 15, 1998
Date of Event
April 28, 1998
Report Date
June 11, 1998
Manufacturer
DEPUY, INC.
Product Code
KYM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WA, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

SURFACE OF GLENOID FRAGMENTED. PT WITH PREVIOUS SHOULDER ARTHROPLASTY IN JAN 1996 FOR DEGENERATIVE JOINT DISEASE. EVIDENCE SUGGESTING UPWARD DISPLACEMENT OF HUMERAL HEAD RELATIVE TO GLENOID.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 GLENOID-DE PUY Implant GLENOID COMPONENT KYM DEPUY, INC. PEGGED GLENOID *

Patients

Seq Age Sex Outcome Treatment
1 79 YR Other