BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIMMER M/L TAPER KENECTIV FEMORAL STEM

    MDR report key: 2539395 · Received April 11, 2012

    Report

    Report Number
    1822565-2012-00762
    Event Type
    Death
    Date Received
    April 11, 2012
    Date of Event
    May 1, 2009
    Report Date
    March 12, 2012
    Manufacturer
    ZIMMER, INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ACCORDING TO THE MEDICAL HISTORY PROVIDED, THE PATIENT HAD A HISTORY OF PULMONARY EMBOLUS AND THIS IS LISTED AS THE PRIMARY CAUSE OF DEATH ON THE PROVIDED CERTIFICATE OF DEATH. THE SECONDARY CAUSES WERE LISTED AS STAPHYLOCOCCUS AUREUS BACTEREMIA AND SEPTIC ARTHRITIS. IT IS ALSO INDICATED IN THE MEDICAL HISTORY PROVIDED THAT THE SOURCE OF THE INFECTION WAS A DENTAL PROCEDURE WHERE THE BACTERIA WERE RESISTANT TO THE PROPHYLACTIC ANTIBIOTIC RECEIVED FOR THIS PROCEDURE AND THAT THIS IS WHAT LED TO THE SEPTIC HIP. THE MANUFACTURING LOTS SPECIFIED IN THIS COMPLAINT WERE PROCESSED ACCORDING TO THE VALIDATED STERILIZATION PROCESS PARAMETERS AND MET ALL THE ACCEPTANCE CRITERIA FOR STERILITY RELEASE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION, IT IS HIGHLY UNLIKELY THAT THE DEVICES WERE THE ROOT CAUSE OF THIS EVENT. EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS DID NOT FIND ANY DEVIATIONS OR ANOMALIES. IT IS NOT SUSPECTED THAT THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PRODUCT CONTRIBUTION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT DIED APPROXIMATELY 1 YEAR AFTER RECEIVING A TOTAL HIP ARTHROPLASTY. THE CAUSE OF DEATH WAS REPORTED TO BE PULMONARY EMBOLUS, SECONDARY TO STAPHYLOCOCCUS AUREUS BACTEREMIA AND SEPTIC ARTHRITIS. IT IS ALSO REPORTED THAT THE SOURCE OF THE INFECTION WAS FROM A DENTAL PROCEDURE THAT RESULTED IN THE SEPTIC HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER M/L TAPER KENECTIV FEMORAL STEM KWA ZIMMER, INC. 60815992

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death THE FOLLOWING WERE MANUFACTURED BY ZIMMER| LOT# 2430914| LOT# 60825923| METASUL LDH HEAD ADAPTOR: CATALOG# 01.00185.146| LOT# 233414| KINECTIV MODULAR NECK: CATALOG# 00784802400| METASUL DUROM ACETABULAR COMPONENT:| METASUL LDH HEAD: CATALOG# 01.00181.560| (B)(4)| CATALOG# 01.00214.162, LOT# 2331078