BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERASUL, HEAD, M/0, TAPER 12/14

    MDR report key: 9271006 · Received November 4, 2019

    Report

    Report Number
    0009613350-2019-00643
    Event Type
    Injury
    Date Received
    November 4, 2019
    Report Date
    May 7, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    JDI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. PART SPECIFIC INVESTIGATION: LESS THAN 3 SIMILAR INVESTIGATED EVENTS WITHIN THE LAST 1 MONTH AND LESS THAN 6 SIMILAR INVESTIGATED EVENTS WITHIN THE LAST 6 MONTHS PRIOR TO THE EVENT DATE HAVE BEEN FOUND FOR THESE ITEM NUMBERS. RESULT: ISSUE EVALUATION REQUEST IS NOT REQUIRED. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CERASUL ALPHA INSERT ON AN UNKNOWN DATE IN 2004 AND IS YET TO UNDERGO REVISION SURGERY DUE TO IMPLANT FRACTURE. ADDITIONAL INFORMATION REVEALED THAT THE REVISION SURGERY WAS PERFORMED ON OCTOBER 17, 2019. REVIEW OF RECEIVED DATA NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS WERE RECEIVED. DEVICES ANALYSIS: UPON RECEIPT THE CERAMIC INLAY OF THE CERASUL ALPHA INSERT IS FRACTURED AND DETACHED FROM THE POLYETHYLENE LINER. THE HEAD IS ALSO RECEIVED AND IS FRACTURED. SOME INDIVIDUAL FRAGMENTS ARE ALSO RECEIVED - HOWEVER IT IS NOT POSSIBLE FOR ALL THE FRAGMENTS TO IDENTIFY IF THEY BELONG TO THE LINER OR THE HEAD. ONE BIGGER FRACTURE FRAGMENT OF THE HEAD WAS RECEIVED FOR INVESTIGATION. THE ARTICULATION SURFACE OF THE CERASUL HEAD EXHIBITS A LARGE AREA WITH WEAR AND SOME INDENTS. A FEW INDIVIDUAL METALLIC SMEARING IN FORM OF DOTS AND LINES CAN BE OBSERVED ON THE ARTICULATION SURFACE AS WELL AS ON THE FRACTURE SURFACE. THE TAPER SHOWS METALLIC SMEARING REFLECTING THE COMMONLY OBSERVED SEATING PATTERN INDICATING A PROPER SEATING ON THE STEM. FURTHER, NO CONSPICUOUSNESS COULD BE IDENTIFIED. THE POLYETHYLENE LINER IS WORN ON THE INNER SIDE. THE LATTER EXHIBITS A ROUGH ABRADED APPEARANCE AND SOME ACCUMULATION OF METALLIC WEAR PARTICLES. THE BACKSIDE OF THE INSERT EXHIBITS SOME METALLIC WEAR PARTICLES AS WELL IN ONE AREA. ONE LARGE PIECE OF THE FRACTURED CERAMIC INLAY IS AT HAND. THE FRAGMENT ONLY EXHIBITS SLIGHT METALLIC SMEARING ON THE RIM OF THE INLAY. REVIEW OF PRODUCT DOCUMENTATION ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION SUMMARY: PATIENT WAS IMPLANTED WITH A CERASUL ALPHA INSERT ON AN UNKNOWN DATE IN 2004 AND UNDERWENT REVISION SURGERY DUE TO IMPLANT FRACTURE ON (B)(6) 2019. NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. THE QUALITY RECORDS ALSO SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE CERASUL HEAD AND THE CERASUL ALPHA INSERT WERE RECEIVED FOR INVESTIGATION. UPON RECEIPT THE CERAMIC INLAY OF THE CERASUL ALPHA INSERT IS FRACTURED AND DETACHED FROM THE POLYETHYLENE LINER AND THE HEAD IS ALSO FRACTURED. BASED ON THIS VISUAL EXAMINATION THE REPORTED EVENT CAN BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, IT REMAINS UNKNOWN IF THE LINER OR THE HEAD BROKE FIRST AND IT IS NOT POSSIBLE TO FURTHER IDENTIFY POSSIBLE CONTRIBUTING FACTORS. BASED ON THE INVESTIGATION WE WERE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. NO SURGICAL REPORT OR X-RAYS WERE PROVIDED FOR REVIEW. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE ACTUAL DEVICE REPORTED IN SECTION D IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E REF# (B)(4), BIOLOX DELTA HEADS, K071535) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED. CONCOMITANT DEVICE; ITEM NAME: CERASUL, ALPHA INSERT, JJ/28, REF# (B)(4) , LOT # UNKNOWN. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. AS SOON AS ADDITIONAL INFORMATION BECOME AVAILABLE AND/OR AN INVESTIGATION RESULT BE AVAILABLE, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1069490 CERASUL, HEAD, M/0, TAPER 12/14 UNKNOWN JDI ZIMMER GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R