BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY 36MM +3 MAXROM LINER SZ23

    MDR report key: 7477726 · Received May 1, 2018

    Report

    Report Number
    0001825034-2018-03015
    Event Type
    Injury
    Date Received
    May 1, 2018
    Date of Event
    April 11, 2018
    Report Date
    May 9, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MAY
    PMA / PMN Number
    PK090103
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, DUE TO HOSPITAL DISCARDING AS BIOHAZARD. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: BIOMET REGEN/RNGLC+ LTD 52MM SZ 23, ITEM #: PT-116052, LOT#: 315700, BIOMET CER BIOLOXD MOD HD 36MM STD NK, ITEM#: 12-115121, LOT#: 2911053, BIOMET TPRLC 133 FP TYPE1 PPS HO 7.0, ITEM#: 51-101070, LOT#: 2711253. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 03017, 0001825034 - 2018 - 03018.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION 2 DAYS POST-OP DUE TO DISASSOCIATION AND DISLOCATION. NO ANOMALIES WERE NOTICED DURING THE INITIAL SURGERY, BUT SURGEON BELIEVES PATIENT'S ABNORMALLY HIGH BODY MASS INDEX WAS A CONTRIBUTING FACTOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A HIP REVISION 2 DAYS POST-OP DUE TO DISASSOCIATION. NO ANOMALIES WERE NOTICED DURING THE INITIAL SURGERY, BUT SURGEON BELIEVES PATIENT'S ABNORMALLY HIGH BODY MASS INDEX WAS A CONTRIBUTING FACTOR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319363 E-POLY 36MM +3 MAXROM LINER SZ23 HIP PROSTHESIS MAY ZIMMER BIOMET, INC. N/A 247000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R