BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14

    MDR report key: 8595322 · Received May 9, 2019

    Report

    Report Number
    0009613350-2019-00299
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    March 11, 2019
    Report Date
    September 26, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024430280
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: REF#: (B)(4). LOT#: 2834438 - YIELD: 101 - DELIVERED: 101 THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. ASSOCIATED (WINTERTHUR) DEVICE: STEM. REF#:(B)(4). LOT#: 2847140 - YIELD: 28 - DELIVERED: 27 - SCRAPPED: 1 - REASON FOR SCRAPPING: NECK POSITIONING OUT OF TOLERANCE THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: MEDICAL : REVISION DUE TO DISLOCATION EVENT DESCRIPTION: IT WAS REPORTED THAT A BIOLOX DELTA CERAMIC HEAD WAS IMPLANTED TOGETHER WITH AN AVANTAGE INSERT (ZB VALENCE) ON (B)(6) 2017 AND REVISED ON (B)(6)2019 DUE TO DISLOCATION. PATIENT'S BMI IS 31; HE IS 175 CM AND 95 KILOS. THE PATIENT REPORTED HEARING A NOISE WHEN ASSUMING AN UPRIGHT POSITION AND THAT HE COULD NOT MOVE THEREAFTER. REVIEW OF RECEIVED DATA: - X-RAYS REVIEW SHOWS THAT THE HEAD AND THE INSERT ARE DISLOCATED. THE HEAD REMAINS ASSEMBLED IN THE STEM HOWEVER THE INSERT IS NOT ANYMORE IN THE ACETABULAR SOCKET. FIVE PICTURES OF THE EXPLANTED INSERT SHOW BLOOD, AND SEVERAL SCRATCHES AROUND THE RIM. NO PICTURES OF THE BIOLOX DELTA HEAD WERE RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. - THE COMPATIBILITY CHECK WAS PERFORMED FROM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. - INSTRUCTION FOR USE (IFU) FOR BIOLOX IS REVIEWED. DISASSEMBLY OF MODULAR COMPONENTS IS LISTED UNDER ADVERSE EFFECTS. CONCLUSION SUMMARY: BASED ON THE RECEIVED PICTURES OF THE EXPLANTED INSERT AND THE X-RAYS REVIEW, COMPLAINT COULD BE CONFIRMED. HOWEVER, NEITHER THE EXPLANTED HEAD NOR ANY PICTURES OF IT WERE RECEIVED. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). AS PER IFU, COMPLICATIONS AND/OR FAILURE OF PROSTHETIC IMPLANTS ARE MORE LIKELY TO OCCUR IN HEAVY PATIENTS. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. 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). NOTE: THE FOLLOWING REPORT IS ASSOCIATED WITH THIS EVENT: (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM NUMBER: P0561E54, ITEM NAME: AVAN E1 INSERT 28 S, 54 LOT #: 0001202087. ITEM NUMBER: P0460P54, ITEM NAME: AVAN RELD ACET SHL SS HA 54MM HA DIA54MM, LOT #: 0100121030. ITEM NUMBER: 0100121030, ITEM NAME: ALLOCLASSIC®, SL STEM, OFFSET, UNCEMENTED, 3, TAPER 12/14, LOT #: 2847140. THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION OF BIOLOX HEAD AND INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388995 BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 28/-3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER GMBH N/A 2834438 00889024430280

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R