BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCR 6.5X15 SELF-TAP

    MDR report key: 11444327 · Received March 9, 2021

    Report

    Report Number
    0001822565-2021-00627
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    January 15, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED THAT MULTIPLE RIGHT HIP REVISION HAVE BEEN PERFORMED SINCE (B)(6) 2019, WITH A KNOWN HISTORY OF PRIOR RIGHT HIP INFECTION. WITH MULTIPLE SURGICAL REVISION TO RIGHT HIP, INCREASES THE PATIENTS RISK TO DEVELOP INFECTIONS. 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    THE RECEIVED ADDITIONAL INFORMATION DOES NOT CHANGE THE FINAL CONCLUSIONS OF PREVIOUS INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 110010271 ¿ G7 MULTIHOLE SHELL - R3713970A; 11-300817 ¿ ARCOS DISTAL STEM ¿ 838140; 11-301323 ¿ ARCOS CONE - 213330; 30124009 ¿ G7 VIT E HIGH WALL LINER ¿ 64714864; 650-1067 ¿ BIOLOX DELTA TAPER 3031101; 650-1058 ¿ BIOLOX DELTA HEAD ¿ 2993794; 00625006520 - BONE SCREW - 63187339; 00625006540 ¿ BONE SCREW ¿ 63604707; 00625006540 ¿ BONE SCREW ¿ 64202377. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNING FOR THE INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2021 - 00622, 0001822565 - 2021 - 00623, 0001822565 - 2021 - 00625, 0001822565 - 2021 - 00626.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A FIRST STAGE REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION, A SECOND STAGE REVISION APPROXIMATELY 2 MONTHS LATER AND 3 MORE SURGERIES WITHIN A 15 MONTH PERIOD OF TIME. SUBSEQUENTLY, THE PATIENT UNDERWENT ANOTHER REVISION APPROXIMATELY 1 MONTH AFTER THE LAST DUE TO INFECTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343322 BONE SCR 6.5X15 SELF-TAP PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 629035991

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R