BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, HH/32

    MDR report key: 10332503 · Received July 28, 2020

    Report

    Report Number
    0009613350-2020-00343
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    July 16, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    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 WAS IMPLANTED WITH A BIOLOX HEAD AND DURASUL LINER ON (B)(6) 2020 AND UNDERWENT REVISION ON (B)(6) 2020 DUE TO POSSIBLE INFECTION. ANOTHER BIOLOX HEAD WITH A DIFFERENT LOT (2955207) AND ANOTHER DURASUL LINER WITH ANOTHER LOT (2895910) WERE IMPLANTED IN THE REVISION SURGERY. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. 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 DEVICES CERTIFIES THE SUITABILITY OF STERILIZATION. THE IRRADIATION CERTIFICATE OF THE AFFECTED LOT NUMBER HAS BEEN REVIEWED AND WAS FOUND TO BE ACCORDING TO SPECIFICATIONS. BIOLOX HEAD INSTRUCTION FOR USE (IFU): CONTRAINDICATIONS: ACTIVE INFECTION OF THE HIP, OLD OR REMOTE INFECTION. THIS MAY BE AN ABSOLUTE OR RELATIVE CONTRAINDICATION. 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. DURASUL INSERT INSTRUCTION FOR USE (IFU): CONTRAINDICATIONS: ACTIVE INFECTION OF THE HIP, OLD OR REMOTE INFECTION. THIS MAY BE AN ABSOLUTE OR RELATIVE CONTRAINDICATION. 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, BREACHED, OR IF THE EXPIRATION DATE HAS BEEN EXCEEDED. ONCE OPENED, THE COMPONENT MUST BE USED, DISCARDED, OR RESTERILIZED. IF THE PACKAGING IS DAMAGED OR THE STERILITY EXPIRATION DATE HAS BEEN REACHED, THE IMPLANTS MUST BE RETURNED TO THE MANUFACTURER. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A BIOLOX HEAD AND DURASUL LINER ON (B)(6) 2020 AND UNDERWENT REVISION ON(B)(6) 2020 DUE TO POSSIBLE INFECTION. ANOTHER BIOLOX HEAD WITH A DIFFERENT LOT (2955207) AND ANOTHER DURASUL LINER WITH ANOTHER LOT (2895910) WERE IMPLANTED IN THE REVISION SURGERY. NO PRODUCTS WERE RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. NO MEDICAL RECORDS TO ATTEST THE INFECTION HAVE BEEN RECEVIED; THEREFORE, THE REPORTED EVENT COULD NOT BE CONFIRMED. HOWEVER, THE QUALITY RECORDS WERE REVIEWED FOR BOTH LOTS AND SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. ADDITIONALLY, THE STERILIZATION CERTIFICATE WAS REVIEWED FOR BOTH LOTS AND SHOWED THAT THE DEVICES HAVE BEEN TREATED ACCORDING TO THE APPLICABLE STANDARDS WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. THEREFORE THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). THE APPLICABLE INSTRUCTIONS FOR USE (IFU) INDICATE THAT INFECTION IS A POSSIBLE CONSEQUENCE WHEN IMPLANTING ZIMMER BIOMET DEVICES. THEREFORE, EACH PACKAGE MUST BE INSPECTED PRIOR TO USE AND COMPONENTS MUST NOT BE USED IF THE PACKAGING IS DAMAGED OR BREACHED AND ONCE OPENED COMPONENTS MUST BE USED IMMEDIATELY OR HANDLED ACCORDING TO INSTRUCTIONS. NEVERTHELESS, AN INFECTION CAN HAVE NUMEROUS ROOT CAUSES. POSSIBLE CAUSES OF INFECTION INCLUDE WRONG HANDLING OF DEVICE DURING TRANSPORTATION AND /OR STORAGE, CONTAMINATED DEVICE DUE TO PACKAGING FAILURE. ADDITIONALLY PATIENT AND SURGICAL FACTORS WHICH REMAIN UNKNOWN MIGHT HAVE CONTRIBUTED TO THE INFECTION. THEREFORE, BASED ON THE INVESTIGATION AND THE AVAILABLE INFORMATION, WE WERE NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE FOR THIS ISSUE. 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). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: 0009613350-2020-00343, AND 0009613350-2020-00344.

    Description of Event or Problem · 0

    NO CHANGE TO PREVIOUSLY REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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 THE UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794972 DURASUL, ALPHA INSERT, HH/32 DURASUL, ALPHA INSERT, HH/32 LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2939220

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R