BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KERAMOS HIP

    MDR report key: 6570638 · Received May 16, 2017

    Report

    Report Number
    1644408-2017-00367
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    April 17, 2017
    Report Date
    August 28, 2017
    Manufacturer
    ENCORE MEDICAL L.P.
    Product Code
    MRA
    UDI-DI
    00888912075749
    PMA / PMN Number
    D138902
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS THE PATIENT'S CERAMIC HIP LINER BROKE. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 11.8 YEARS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THERE ARE NO REPORTED PRE-EXISTING PATIENT HEALTH CONDITIONS. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS, DESIGN CRITERIA AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED AS NON-PRODUCT RELATED. THE ROOT CAUSE FOR THIS EVENT WAS THE PATIENT'S CERAMIC HIP LINER BROKE. THE COMPLAINT STATES THE PATIENT HIP LINER BROKE. NO INFORMATION WAS PROVIDED THAT FURTHER EXPLAINED THE NATURE OF THE EVENT RELATED TO A POSSIBLE CAUSE AND REASONS. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE EXPLANTED PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR REPORTED 400-01-297, LOT NUMBER 891511 AS THE SUSPECT MEDICAL DEVICE. FOLLOW-UP #1 CORRECTED THE SUSPECT MEDICAL DEVICE TO 498-01-054, LOT NUMBER 224442 AND CORRECTED THE CONCOMITANT PART TO 400-01-297,LOT 891511. QUALITY ASSURANCE HAS CHANGED THE SUSPECT MEDICAL DEVICE TO 498-32-052, LOT NUMBER 221092 WITH THE SAME CONCOMITANT PART OF 400-01-297, LOT NUMBER 891511. FOLLOW-UP #2 IS MAKING THIS CORRECTION AND THE FOLLOWING MANUFACTURER NARRATIVE IS FOR THE CORRECTED SUSPECT MEDICAL DEVICE. MANUFACTURER NARRATIVE: THE REASON FOR THIS REVISION SURGERY WAS THE PATIENT'S CERAMIC HIP LINER BROKE. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 11.8 YEARS. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS, DESIGN CRITERIA AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED AS NON-PRODUCT RELATED. THE ROOT CAUSE FOR THIS EVENT WAS THE PATIENT'S CERAMIC HIP LINER BROKE. NO INFORMATION WAS PROVIDED THAT FURTHER EXPLAINED THE NATURE OF THE EVENT RELATED TO A POSSIBLE CAUSE AND REASONS. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE EXPLANTED PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE LINEAR BREAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349662 KERAMOS HIP LINER, CERAMIC ,AL-AL 32X52/54MM MRA ENCORE MEDICAL L.P. 400-01-297 2231092 00888912075749

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention