BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE +6

    MDR report key: 12539791 · Received September 28, 2021

    Report

    Report Number
    3002806535-2021-00415
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    September 20, 2021
    Report Date
    January 21, 2022
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271502
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FINAL REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SUMMARY: 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. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT ITEM, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION. REVIEW OF COMPLAINT HISTORY IDENTIFIED 11 SIMILAR COMPLAINTS FOR ITEM 650-1055 INCLUDING THE INITIATING COMPLAINT IN THE LAST 3 YEARS, AND NO ADDITIONAL COMPLAINTS FOR THE SAME ITEM AND LOT COMBINATION. REVIEW OF COMPLAINT HISTORY IDENTIFIED NO ADDITIONAL SIMILAR COMPLAINTS FOR ITEM 650-1068 IN THE LAST 3 YEARS, AND NO ADDITIONAL COMPLAINTS FOR THE SAME ITEM AND LOT COMBINATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. 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 REPORTED EVENT. DEVICE IS USED FOR TREATMENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. THE INVESTIGATION IS COMPLETED BASED ON CURRENT AVAILABLE INFORMATION. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN THE COMPLAINT WILL BE REOPENED AND FURTHER INVESTIGATED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00414-1. 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. H3 OTHER TEXT: PRODUCT NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT THE PATIENT DISLOCATED OVER THE WEEKEND AND WAS REVISED FOR INSTABILITY ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. MEDICAL PRODUCT: CER BIOLOXD OPTION HD 28MM, CATALOG #: 650-1055, LOT #: 3050674. MEDICAL PRODUCT: G7 OSSEOTI 4 HOLE SHELL 64MM H, CATALOG #: 110010250, LOT #: 6459948. MEDICAL PRODUCT: VIVACIT-E DM BEARING 28X50MM, CATALOG #: 110031015, LOT #: 64731446. MEDICAL PRODUCT: G7 DUAL MOBILITY LINER 50MM H CATALOG #: 110024466, LOT #: 755990. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00414. 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 DISLOCATED OVER THE WEEKEND AND WAS REVISED FOR INSTABILITY ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438328 CER OPTION TYPE 1 TPR SLEVE +6 HIP PROTHESIS LZO BIOMET UK LTD. N/A 2900905 00887868271502

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R SEE H10 NARRATIVE