BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14

    MDR report key: 10768659 · Received November 2, 2020

    Report

    Report Number
    0009613350-2020-00518
    Event Type
    Injury
    Date Received
    November 2, 2020
    Date of Event
    October 21, 2020
    Report Date
    February 24, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430372
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON (B)(6) 2020. THE PATIENT UNDERWENT A HEAD AND LINER REPLACEMENT AND WASHOUT ON (B)(6) 2020 DUE TO INFECTION. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PATIENT DATA: (B)(6) MALE, BORN (B)(6) 1950, 170 CM, 80 KG. NO MEDICAL DATA, SUCH AS LABORATORY REPORTS, HAVE BEEN RECEIVED. PRODUCT EVALUATION: - NO PRODUCT WAS RETURNED; THEREFORE, EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: - DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. - PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED AS NOT ALL INVOLVED PRODUCTS ARE KNOWN. THE REPORTED LINER AND HEAD ARE COMPATIBLE. - DHR REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. - STERILIZATION CERTIFICATE: THE GAMMA STERILIZATION SPECIFICATION OF THE DEVICE CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT NUMBER HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATIONS. CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AUG 26, 2020. THE PATIENT UNDERWENT A HEAD AND LINER REPLACEMENT AND WASHOUT ON OCT 21, 2020 DUE TO INFECTION. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NONCONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE REPORTED EVENT OF DEEP INFECTION <90 DAYS OCCURRED POST IMPLANTATION. THE STERILIZATION CERTIFICATE WAS REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. THE BIOLOX HEAD WAS 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. THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS, THEREFORE THE IMPLANTED BIOLOX HEAD IS NOT CONSIDERED THE SOURCE OR CONTRIBUTING FACTOR TO THE REPORTED INFECTION. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: G7 HI-WALL E1 LINER 36MM F; CATALOG#: 010000936; LOT#: 6724556. THERAPY DATE: (B)(6) 2020. THE MANUFACTURER RECEIVED OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION. INFECTION OCCURRED LESS THAN 2 MONTHS POST INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234927 BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2994025 00889024430372

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R