FDA Adverse Event Death Summary report: N

ZIMMER

MDR report key: 184661 · Received August 26, 1998

Report

Report Number
1822565-1998-00102
Event Type
Death
Date Received
August 26, 1998
Date of Event
July 14, 1998
Report Date
July 31, 1998
Manufacturer
ZIMMER, INC.
Product Code
LOD
Removal / Correction Number
NA
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

DURING A FEMORAL HEAD REPLACEMENT SURGERY, BONE CEMENT WAS APPLIED. BEFORE SUTURING TISSUE AND AFTER POLYMERIZATION, PT'S PULSE AND BLOOD PRESSURE DROPPED SUDDENLY. PT WAS RECOVERED MOMENTARILY BY CARDIO PULMONARY RESUSCITATION BUT EVENTUALLY DIED OF CARDIOGENIC SHOCK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ZIMMER Implant LVC BONE CEMENT SGL 80/40/KIT LOD ZIMMER, INC. NA 53787800

Patients

Seq Age Sex Outcome Treatment
1 97 YR Death