BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 13480258 · Received February 8, 2022

    Report

    Report Number
    3002806535-2022-00053
    Event Type
    Injury
    Date Received
    February 8, 2022
    Date of Event
    January 14, 2022
    Report Date
    March 8, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271465
    PMA / PMN Number
    K200959
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED TO ZIMMER BIOMET FOR AN INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 46MM G; CATALOGUE NUMBER: 110024465; LOT NUMBER: 371300. MEDICAL PRODUCT: UNKNOWN DM POLY LINER; CATALOGUE NUMBER: UNKNOWN DM POLY LINER; LOT NUMBER: UNKNOWN. MEDICAL PRODUCT: ARCOS CON SZ B STD 60MM; CATALOGUE NUMBER: 11-301302; LOT NUMBER: 360360. MEDICAL PRODUCT: 3.2MMX30MM RNGLC+ ACET DRL BIT; CATALOGUE NUMBER: 31-323230; LOT NUMBER: 082320. MEDICAL PRODUCT: ARCOS 18X150MM SPL TPR DIST; CATALOGUE NUMBER: 11-300818; LOT NUMBER: 221260. MEDICAL PRODUCT: CER OPTION TYPE 1 TPR SLEVE -6; CATALOGUE NUMBER: 650-1064; LOT NUMBER: 3032903. MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 46MM G; CATALOGUE NUMBER: 110024465; LOT NUMBER: 110024465. MEDICAL PRODUCT: VIVACIT-E DM BEARING 28X46MM; CATALOGUE NUMBER: 110031013; LOT NUMBER: 65016432. MEDICAL PRODUCT: BONE SCR 6.5X35 SELF-TAP; CATALOGUE NUMBER: 00625006535; LOT NUMBER: J6851898. MEDICAL PRODUCT: BONE SCR 6.5X35 SELF-TAP; CATALOGUE NUMBER: 00625006535; LOT NUMBER: J6851905. MEDICAL PRODUCT: G7 OSSEOTI MULTIHOLE 58MM G; CATALOGUE NUMBER: 110010267; LOT NUMBER: 6512782. THE INVESTIGATION IS CURRENTLY UNDERWAY. ONCE THE INVESTIGATION HAS CONCLUDED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION, THEREFORE THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS, AND A COMPLAINT HISTORY SEARCH. THE DEVICE IS USED FOR TREATMENT. A DHR REVIEW IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. A REVIEW OF COMPLAINT HISTORY IDENTIFIED 14 SIMILAR COMPLAINTS ABOUT THE REPORTED ITEM NUMBER, AND NO ADDITIONAL COMPLAINTS FOR THE SAME ITEM AND LOT COMBINATION FOR 3 YEARS PRIOR TO THE NOTIFICATION DATE IT HAS BEEN CONFIRMED THAT THE ITEM IS NOT WITHIN THE SCOPE OR SUBJECT OF ANY FIELD ACTIONS OR RECALLS WHICH COULD BE ATTRIBUTED TO THE REPORTED EVENT. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER THE INVESTIGATION OF THIS EVENT. WE HAVE NOT BEEN PROVIDED WITH X-RAYS OR ANY SUPPORTING DOCUMENTATION WHICH COULD PROVIDE ADDITIONAL INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS CONFORMING TO THE SPECIFICATION. THE REPORTED EVENT HAS NOT BEEN CONFIRMED AS THE PRODUCTS HAVE NOT BEEN RETURNED FOR EVALUATION AND THE DHR REVIEW DID NOT IDENTIFY ANY ISSUES. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE SUBMITTED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT: A PATIENT UNDERWENT A REVISION OF THE RIGHT HIP ON (B)(6) 2021, DUE TO UNKNOWN REASONS. SUBSEQUENTLY, A REVISION PROCEDURE DUE TO DISLOCATION (FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER) WAS PERFORMED ON (B)(6) 2022. NO FURTHER OUTCOME.

    Description of Event or Problem · 0

    THE PATIENT BECAME DISLOCATED AND COULD NOT BE REDUCED THROUGH CLOSE REDUCTION. HAD TO OPEN AND FOUND FEMORAL HEAD BECAME DISASSOCIATED FROM DM POLY LINER. DM CONSTRUCT REMOVED AND FREEDOM CONSTRUCT PUT IN PLACE. NO FURTHER OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757621 CER BIOLOXD OPTION HD 28MM BIOLOX DELTA CERAMIC OPTION HD LZO BIOMET UK LTD. N/A 3062495 00887868271465

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Hospitalization| R SEEH10