BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 36MM

    MDR report key: 9937646 · Received April 8, 2020

    Report

    Report Number
    3002806535-2020-00229
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 12, 2020
    Report Date
    August 19, 2020
    Manufacturer
    .
    Product Code
    LPH
    UDI-DI
    00887868271397
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 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 1 SIMILAR COMPLAINTS REPORTED WITH THESE ITEM 650-1057. TREND IDENTIFIED AS OTHER COMPLAINT IS FROM SAME HOSPITAL AND SAME DOCTOR. ROOT CAUSE COULD NOT BE IDENTIFIED IN THAT CASE AS PRODUCT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. HOSPITAL AND SURGEON INFORMATION UPDATED. D10: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE REMAINS IMPLANTED. D11: ITEM NAME : G7 PPS LTD ACET SHELL 50D, ITEM #: 010000662, LOT # 6149828. ITEM NAME : G7 NEUTRAL E1 LINER 36MM D, ITEM #:010000856, LOT # 6025178. ITEM NAME : ECHO B-MTRC MP FP HO 8, ITEM #:193108 LOT # 66931OR. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP/FINAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICAL STUDY (B)(4) THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT THE TWO YEAR VISIT, THE PATIENT REPORTED INCREASED PAIN , STIFFNESS AND A DECREASE IN SATISFACTION. A BONE SCAN WAS PERFORMED AND MRI PLANNED. PATIENT OPTED OUT OF MRI.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CLINICAL STUDY ECHO_AM166H THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT THE TWO YEAR VISIT, THE PATIENT REPORTED INCREASED PAIN AND A DECREASE IN SATISFACTION. A BONE SCAN WAS PERFORMED AND MRI PLANNED. NO FURTHER INTERVENTION HAS BEEN REPORTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORT. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE DEVICE REMAINS IMPLANTED. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: G7 PPS LTD ACET SHELL 50D, ITEM #: 010000662, LOT # 6149828. ITEM NAME: G7 NEUTRAL E1 LINER 36MM D, ITEM #:010000856, LOT # 6025178. ITEM NAME: ECHO B-MTRC MP FP HO 8, ITEM #:193108, LOT # 66931OR. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CLINICAL STUDY(B)(6) THAT PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, AT THE TWO YEAR VISIT, THE PATIENT REPORTED INCREASED PAIN AND A DECREASE IN SATISFACTION. A BONE SCAN WAS PERFORMED AND MRI PLANNED. NO FURTHER INTERVENTION HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403630 CER BIOLOXD OPTION HD 36MM HIP PROTHESIS LPH . N/A 2904536 00887868271397

    Patients

    Seq Age Sex Outcome Treatment
    1 Other