FDA Adverse Event Injury Summary report: N

ZIMMER

MDR report key: 93066 · Received May 21, 1997

Report

Report Number
39747-1997-00001
Event Type
Injury
Date Received
May 21, 1997
Date of Event
March 25, 1997
Report Date
May 14, 1997
Manufacturer
ZIMMER, INC.
Product Code
LOD
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
IL, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

HIP REVISION, FEMORAL STEM, PRE-OP DIAGNOSIS ASEPTIC LOOSENING LEFT HIP, OTHER DEVICE USED CENTRALIGN #4 STEM FEMORAL HEAD (9800-04 AND 9026-29) (LOT #64241800 AND #63979100). EXPLANTED ITEMS WERE SENT TO PATHOLOGY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ZIMMER Implant DOUGH TYPE BONE CEMENT LOD ZIMMER, INC. * 63843900

Patients

Seq Age Sex Outcome Treatment
1 77 YR Required Intervention UNK.