BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER OPTION TYPE 1 TPR SLEVE -6

    MDR report key: 12613513 · Received October 12, 2021

    Report

    Report Number
    3002806535-2021-00443
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    May 27, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BIOMET UK LTD.
    Product Code
    OQG
    UDI-DI
    00887868271465
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, AND X-RAYS OR MEDICAL NOTES HAVE NOT BEEN PROVIDED. THEREFORE, THE INVESTIGATION HAS BEEN LIMITED TO THE INFORMATION PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS, AND A COMPLAINT HISTORY SEARCH. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING THAT COULD BE RELATED TO THE REPORTED EVENT. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED 10 SIMILAR COMPLAINTS FOR ITEM 650-1055. THERE WERE NO ADDITIONAL COMPLAINTS AGAINST THE LOT 2898728. A REVIEW OF COMPLAINT HISTORY WAS ASSESSED FOR THREE YEARS PRIOR TO THE NOTIFICATION DATE AND IDENTIFIED 2 SIMILAR COMPLAINTS FOR ITEM 650-1064. THERE WERE NO ADDITIONAL COMPLAINTS AGAINST THE LOT 2900788. THESE DEVICES ARE USED FOR TREATMENT. THE IMPLANTS USED HAVE BEEN CONFIRMED TO BE COMPATIBLE. THESE PART AND LOT COMBINATIONS ARE NOT ASSOCIATED WITH ANY RECALLS AT THE TIME THE SEARCH WAS CONDUCTED. THE LIKELY CONDITION OF THE DEVICES WHEN THEY LEFT ZIMMER BIOMET IS CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. CAPA: NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED AT THIS TIME. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2021-00442-1. 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.

    Description of Event or Problem · 0

    THE E1 ACTIVE ARTICULATION BEARING OF THE G7 DUAL MOBILITY IMPLANTED ON (B)(6) 2017 HAS DISLODGED FROM THE AETABULAR CUP. THE PATIENT WAS SUSPECTED OF HAVING IPD WHEN HE UNDERWENT MANUAL REDUCTION DUE TO THE HEAD BEING REMOVED FROM THE E1AA BEARING. IT WAS CONFIRMED THAT THE BEARING HAD COME OFF THE CUP DURING THE REVISION SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ASSOCIATED PRODUCTS: MEDICAL PRODUCT: ACT ARTIC E1 HIP BRG 28X40MM; CATALOG NO.: EP-200146; LOT NO.: 783390. MEDICAL PRODUCT: M2A-MAGNUM PF CUP 46ODX40ID; CATALOG NO.: US157846; LOT NO.: 030360. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 3002806535-2021-00442. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. ITEM NOT RETURNED.

    Description of Event or Problem · 1

    THE E1 ACTIVE ARTICULATION BEARING OF THE G7 DUAL MOBILITY IMPLANTED ON (B)(6) 2017 HAS DISLODGED FROM THE AETABULAR CUP. THE PATIENT WAS SUSPECTED OF HAVING IPD WHEN HE UNDERWENT MANUAL REDUCTION DUE TO THE HEAD BEING REMOVED FROM THE E1AA BEARING. IT WAS CONFIRMED THAT THE BEARING HAD COME OFF THE CUP DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1515771 CER OPTION TYPE 1 TPR SLEVE -6 CER BIOLOXD OPT TYPE 1 TPR SLV OQG BIOMET UK LTD. N/A 2900788 00887868271465

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R