BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 32MM

    MDR report key: 9161777 · Received October 7, 2019

    Report

    Report Number
    3002806535-2019-00799
    Event Type
    Injury
    Date Received
    October 7, 2019
    Date of Event
    June 18, 2019
    Report Date
    April 23, 2020
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    PMA / PMN Number
    K082996
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED. D11: MEDICAL PRODUCT: ARCOMXL 32MM RLC LNR +5MM SZ22, CATALOG#: XL-155232, LOT#: 122160, MEDICAL PRODUCT: RNGLC LOCKING RING SZ 22, CATALOG#: 105422, LOT#: 227900, MEDICAL PRODUCT: CER OPTION TYPE 1 TPR SLEVE -6, CATALOG#: 650-1064, LOT#: 2914160, MEDICAL PRODUCT: BONE SCR 6.5X50 SELF-TAP, CATALOG#: 00625006550, LOT#: 64143387, MEDICAL PRODUCT: R/B RLOC LHOLE SHL 48MM SZ22, CATALOG#: 11-106048, LOT#: 174800, MEDICAL PRODUCT: BI-METRIC/X POR NC 7X115, CATALOG#: X180307, LOT#: 773480. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FINAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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 THE ITEM 650-1056. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. 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 WAS REVISED DUE TO DISLOCATION APPROXIMATELY 13 MONTHS IMPLANTATION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION: REVISION: ON (B)(6) 2019 AT KAISER FOLLOWING HER 3 DISLOCATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION APPROXIMATELY 13 MONTHS IMPLANTATION. REVISION:(B)(6) 2019 AT (B)(6) FOLLOWING HER 3 DISLOCATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: ARCOMXL 32MM RLC LNR +5MM SZ22 CATALOG #: XL-155232 LOT #: 122160, MEDICAL PRODUCT: RNGLC LOCKING RING SZ 22 CATALOG #: 105422 LOT #: 227900, MEDICAL PRODUCT: CER OPTION TYPE 1 TPR SLEVE -6 CATALOG #: 650-1064 LOT #: 2914160, MEDICAL PRODUCT: BONE SCR 6.5X50 SELF-TAP CATALOG #: 00625006550 LOT #: 64143387 MEDICAL PRODUCT: R/B RLOC LHOLE SHL 48MM SZ22 CATALOG #: 11-106048 LOT #: 174800, MEDICAL PRODUCT: BI-METRIC/X POR NC 7X115 CATALOG #: X180307 LOT #: 773480. REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT HAD AN INITIAL RIGHT THA. THE PATIENT WAS REVISED DUE TO METALLOSIS. SUBSEQUENTLY, THE PATIENT DISLOCATED HER REVISION RTHA REQUIRING A CLOSED REDUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955861 CER BIOLOXD OPTION HD 32MM HIP PROSTHESIS LZO BIOMET UK LTD. N/A 2898752

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R