BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 16213064 · Received January 20, 2023

    Report

    Report Number
    0009613350-2023-00018
    Event Type
    Injury
    Date Received
    January 20, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 14, 2023
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00887868271373
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE: FOREIGN AUSTRALIA. CONCOMITANT MEDICAL PRODUCTS: 650-1064 ¿ CERAMIC TAPER ¿ 3064989; 650-1055 ¿ CERAMIC HEAD ¿ 2020011173; 110010267 - G7 OSSEOTI MULTIHOLE 58MM G - 7196541; EP-200152 - ACT ARTIC E1 HIP BRG 28X46MM - 930800; 110024465 - G7 DUAL MOBILITY LINER 46MM G - 106480; 010000997 - G7 SCREW 6.5MM X 20MM - 7165751; 010001001 - G7 SCREW 6.5MM X 40MM - 6984426; 010000999 - G7 SCREW 6.5MM X 30MM - 7289383; 11-301305 - ARCOS CON SZ E STD 60MM - 037720; UNK ARCOS STEM - UNK ARCOS STEM - UNKNOWN; 47249009700 ¿ TEAR DROP GUIDE WIRE ¿ 65316177; 166069 ¿ ARCOS SCREW ¿ 6828663; 166069 ¿ ARCOS SCREW ¿ 7032015; 166070 ¿ ARCOS SCREW ¿ 6970413; 166068 ¿ ARCOS SCREW ¿ 7053131; 166067 ¿ ARCOS SCREW ¿ 7197916. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0009613350-2023-00017. PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS THE PRODUCT WAS DISCARDED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION AS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D9, D10, G3, G6, H1, H2, H3, H6, H10. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. DEVICES WERE VERIFIED TO HAVE GONE THROUGH ACCEPTABLE STERILIZATION PROCESS FOLLOWING ISO/AAMI/ASTM & EU PUBLISHED GUIDELINES. THERE ARE MULTIPLE FACTORS THAT MAY CONTRIBUTE TO AN INFECTION THAT ARE OUTSIDE THE CONTROL OF ZIMMER BIOMET, SUCH AS EXTERNAL FACTORS, I.E. HOSPITAL/SURGICAL ENVIRONMENT, PROVIDER RELATED RISK FACTORS, AND/OR PATIENT COMORBIDITIES/RISK FACTORS. AS THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUES IDENTIFIED AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE IMPLANTED PRODUCTS ARE NOT IDENTIFIED AS THE SOURCE OR CONTRIBUTING TO THE REPORTED INFECTION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A INITIAL LEFT HIP REVISION ARTHROPLASTY. APPROXIMATELY, ONE MONTH LATER THE PATIENT UNDERWENT A 1ST STAGE REVISION DUE BACTERIAL INFECTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364358 CER BIOLOXD OPTION HD 28MM HIP PROSTHESIS LZO ZIMMER GMBH N/A 2020011173 00887868271373

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE