BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -6

    MDR report key: 9727198 · Received February 19, 2020

    Report

    Report Number
    3002806535-2020-00088
    Event Type
    Injury
    Date Received
    February 19, 2020
    Date of Event
    December 7, 2015
    Report Date
    February 19, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00880304521926
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 28MM, CATALOG #: 650-1055, LOT #: 727470. MEDICAL PRODUCT: M2A-MAGNUM RECAP CUP 58ODX52ID, CATALOG #: 157858, LOT #: 043360. MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X52MM, CATALOG #: EP-200158, LOT #: 235260. MEDICAL PRODUCT: M2A-MAGNUM 52-60MM TPR INSRT-6, CATALOG #: 139264, LOT #: 004100. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00089-1. AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. IN ADDITION, WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE MANUFACTURING HISTORY RECORDS CONFIRMS NO ABNORMALITIES OR DEVIATIONS REPORTED. A REVIEW OF THE COMPLAINT DATABASE OVER THE LAST 3 YEARS HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THESE ITEMS. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: THE EVENT REPORTS HIP REVISION DUE LEG LENGTH DISCREPANCY. RISK MANAGEMENT REPORT DOCUMENTS THE ESTIMATED RESIDUAL RISK ASSOCIATED WITH THE REPORTED EVENT. THE ROOT CAUSE OF THE ISSUE COULD NOT BE DETERMINED WITH THE INFORMATION CURRENTLY AVAILABLE, THEREFORE THE SPECIFIC FAILURE CAUSE WITHIN THE RISK TABLES COULD NOT BE SELECTED FOR COMPARISON. THE REPORTED EVENT STATES HIP REVISION DUE LEG LENGTH DISCREPANCY. THE SEVERITY SCORE IS 3, WHICH IS DEFINED IN THE RMR AS: PRESCRIBED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR BODY STRUCTURE. CONTRIBUTED TO MINOR, TEMPORARY, OR MEDICALLY REVERSIBLE INJURY. THEREFORE, THE OUTCOME OF THE REPORTED EVENT (SURGICAL INTERVENTION) IS IN LINE WITH THE RMF. CORRECTIVE ACTION TAKEN: NO CORRECTIVE ACTION REQUIRED AT THIS TIME. PREVENTIVE ACTION TAKEN: NO PREVENTIVE ACTION REQUIRED AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND INVESTIGATED THOROUGHLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO COMPLICATIONS WITH METAL ON METAL IMPLANTS. PATIENT WAS AGAIN REVISED DUE TO LEG LENGTH DISCREPANCY. THIS COMPLAINT IS REPORTING THE REVISION DUE TO THE LEG LENGTH DISCREPANCY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: CER BIOLOXD OPTION HD 28MM, CATALOG #: 650-1055, LOT #: 727470. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2020-00089. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INITIAL RIGHT HIP REPLACEMENT. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO COMPLICATIONS WITH METAL ON METAL IMPLANTS. PATIENT WAS AGAIN REVISED DUE TO LEG LENGTH DISCREPANCY. THIS COMPLAINT IS REPORTING THE REVISION DUE TO THE LEG LENGTH DISCREPANCY. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193804 CER OPTION TYPE 1 TPR SLEVE -6 FEMORAL HEAD/STEM PROSTHESIS ADAPTOR LZO BIOMET UK LTD. N/A 265000 00880304521926

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEEH10