BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 32MM +3 MAXROM LINER SZ22

    MDR report key: 3346551 · Received September 13, 2013

    Report

    Report Number
    0001825034-2013-03727
    Event Type
    Injury
    Date Received
    September 13, 2013
    Date of Event
    August 12, 2013
    Report Date
    January 30, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND/OR FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS."

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION CONCOMITANT MEDICAL PRODUCTS: 163543, 32MM OFFSET COCR MOD HD +3MMNK, 506650. THE REPORTED EVENT WAS UNABLE BE CONFIRMED AS SURGICAL OP NOTES OR X-RAYS WERE NOT PROVIDED. DEVICE HISTORY RECORDS WERE REVIEWED NO DEVIATIONS OR ANOMALIES WERE FOUND. REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09791.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY ON (B)(6) 2012. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED ON (B)(T) 2013 DUE TO INSTABILITY. THE POLYETHYLENE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A CUSTOM CONSTRAINED LINER AND HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, A REVISION PROCEDURE WAS PERFORMED DUE TO INSTABILITY. THE POLYETHYLENE ACETABULAR LINER AND MODULAR HEAD WERE REMOVED AND REPLACED WITH A CUSTOM CONSTRAINED LINER AND HEAD. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462555 E-POLY 32MM +3 MAXROM LINER SZ22 PROSTHESIS, HIP MAY BIOMET ORTHOPEDICS N/A 710070

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R