BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14

    MDR report key: 10313244 · Received July 23, 2020

    Report

    Report Number
    0009613350-2020-00335
    Event Type
    Injury
    Date Received
    July 23, 2020
    Date of Event
    June 22, 2020
    Report Date
    January 7, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430365
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 PRODUCT WAS IMPLANTED ON (B)(6) 2020 AND REVISED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT UNDERWENT WASHOUT (I&D) AND REPLACEMENT OF THE HEAD AND LINER. 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), FEMALE, (B)(6) 1966, 78 KG. X-RAY: ONE UNDATED RADIOGRAPH WITH POOR IMAGE QUALITY DUE TO POOR RESOLUTION WAS RECEIVED AND NOT CONSIDERED FOR INVESTIGATION FOR THE REASONS STATED. OTHERWISE, NO MEDICAL RECORDS, IMAGES OR ADDITIONAL PATIENT INFORMATION ARE AVAILABLE PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. 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. INSTRUCTION FOR USE BIOLOX DELTA CERAMIC FEMORAL HEAD: PRECAUTIONS: SURVEILLANCE FOR NEW OR RECURRENT SOURCES OF INFECTION SHOULD BE CONTINUED AS LONG AS THE DEVICE IS IN PLACE. STERILITY: THESE DEVICES ARE PROVIDED STERILE AND REMAIN STERILE AS LONG AS THE PACKAGE INTEGRITY HAS NOT BEEN VIOLATED. INSPECT EACH PACKAGE PRIOR TO USE AND DO NOT USE THE COMPONENT IF ANY SEAL OR CAVITY IS DAMAGED OR BREACHED OR IF THE EXPIRATION DATE HAS BEEN EXCEEDED. ONCE OPENED, THE COMPONENT MUST BE USED IMMEDIATELY OR DISCARDED. BIOLOX DELTA CERAMIC FEMORAL HEADS MUST NOT BE RESTERILIZED BY ANY METHOD. CONCLUSION: IT WAS REPORTED THAT THE PRODUCT WAS IMPLANTED ON (B)(6) 2020 AND REVISED ON (B)(6) 2020 DUE TO INFECTION. THE PATIENT UNDERWENT WASHOUT (I&D) AND REPLACEMENT OF THE HEAD AND LINER. 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 NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). IN CONCLUSION, THE REPORTED EVENT OF SUPERFICIAL INFECTION <30 DAYS OCCURRED POST IMPLANTATION. DURING THE INVESTIGATION PROCESS A REVIEW OF THE STERILE CERTIFICATIONS WERE REVIEWED AND FOUND TO BE CONFORMING WITH NO APPLICABLE DEVIATIONS. 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. 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: LINER STANDARD 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 50/52/54 MM O.D. SHELLS; CATALOG NO#: 00630505036; LOT#: 64629595; 52MM REPLACEMENT LOCK RING; CATALOG NO#: 00620105200; LOT#: 63220995; THERAPY DATE: (B)(6) 2020. THE MANUFACTURER DID RECEIVE X-RAYS, OR 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. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT REVISION SURGERY DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778028 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 36/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3011834 00889024430365

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R