BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    CER BIOLOXD OPTION HD 40MM

    MDR report key: 11433452 · Received March 8, 2021

    Report

    Report Number
    3002806535-2021-00073
    Event Type
    Injury
    Date Received
    March 8, 2021
    Date of Event
    December 16, 2020
    Report Date
    March 30, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). AS THE PRODUCT HAS NOT BEEN RECEIVED, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED; A REVIEW OF DEVICE HISTORY RECORDS AND COMPLAINT HISTORY. 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 2 SIMILAR COMPLAINTS REPORTED WITH THE ITEM 650-1058 (INCLUDING INITIATING COMPLAINT). WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. RISK ASSESSMENT: -ROOT CAUSE: 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. AT THIS TIME, NO RISK ASSESSMENT CAN BE CONDUCTED SINCE THE HARM OR REASON FOR REVISION HAS NOT BEEN BE REPORTED. IF FURTHER INFORMATION REGARDING THE ROOT CAUSE OF THE REPORTED EVENT OR REASON FOR REVISION ARE PROVIDED, THE RISK WILL BE RE-ASSESSED. OCCURRENCE RATE ASSESMENT: FEB 12 2018 TO FEB 12 2021: (B)(4) ITEMS SOLD THE GIVEN PERIOD. -NUMBER OF SIMILAR COMPLAINTS IDENTIFIED: 2 (INCLUDING INITIATING COMPLAINT) -OCCURRENCE RATIO: (B)(4). NO CORRECTIVE OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY 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 THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 7 MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD AND LINER WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT ASSOCIATED ITEMS: CAT #110017228 G7 NEU +5MM E1 LINER 40MM I LOT #6326653; CAT #110010271 G7 OSSEOTI MULTIHOLE 66MM I LOT #R3713970A; CAT #650-1066 CER OPT TYPE 1 TPR SLEVE 0MM LOT #2971099. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 THE PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 7 MONTHS POST IMPLANTATION DUE TO UNKNOWN REASONS. THE HEAD AND LINER WERE REMOVED AND REPLACED. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336636 CER BIOLOXD OPTION HD 40MM HIP PROTHESIS LPH BIOMET UK LTD. N/A 2958882

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R SEE H10 NARRATIVE