BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14

    MDR report key: 13665525 · Received March 4, 2022

    Report

    Report Number
    0009613350-2022-00123
    Event Type
    Injury
    Date Received
    March 4, 2022
    Date of Event
    February 4, 2022
    Report Date
    June 30, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430303
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: AVAN E1 INSERT 28 S 60; CATALOG#: P0561E60; LOT#: 0001480321. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE WAS RECEIVED. THE DEVICE HISTORY RECORDS WILL BE REVIEWED DURING INVESTIGATION. 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).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. PRODUCT WAS NOT RETURNED OR PICTURES NOT PROVIDED. VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE MANUFACTURING QUALITY RECORD INDICATE THAT THE RELEASED PRODUCT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. THIS DEVICE IS USED FOR TREATMENT. THE PRODUCTS INVOLVED IN THE COMPLAINT ARE NOT COMPATIBLE. INDEED, THE BIRMINGHAM CUP (MANUFACTURED BY SMITH AND NEPHEW) IMPLANTED IS NOT COMPATIBLE WITH THE AVANTAGE INSERT / BIOLOX DELTA CERAMIC HEAD USED. THE IFU D011500245 ED. 2016/05 FOR CERAMIC HEADS DESCRIBES THE FOLLOWING: DUE TO THE ACQUISITION OF PRE-EXISTING PRODUCT LINES, ZIMMER HAS INITIATED A TESTING PROGRAM TO EVALUATE THE COMPATIBILITY OF THESE DEVICES WITH IMPLANTS AND COMPONENTS MADE OR DISTRIBUTED BY ALL ZIMMER ORTHOPAEDIC COMPANIES, WHICH INCLUDE ZIMMER GMBH (PREVIOUSLY CENTERPULSE ORTHOPEDICS LTD.), ZIMMER, INC., ZIMMER TRABECULAR METAL TECHNOLOGY, INC. (PREVIOUSLY IMPLEX CORP.), ZIMMER UK LTD., ZIMMER AUSTIN, INC. (PREVIOUSLY CENTERPULSE ORTHOPEDICS, IN C.) AND BIOMET ORTHOPAEDIC COMPANIES. ONLY AUTHORIZED COMBINATIONS MUST BE USED. COMPLAINT HISTORY IDENTIFIED ADDITIONAL SIMILAR COMPLAINTS FOR THE REPORTED ITEM AND NO ADDITIONAL COMPLAINTS FOR THE REPORTED PART/LOT COMBINATION. COMPLAINTS ARE MONITORED THROUGH MONTHLY COMPLAINT REVIEW IN ORDER TO IDENTIFY POTENTIAL ADVERSE TRENDS. REPORTED EVENT IS NOT RELATED TO MEDICAL CONDITION. REVIEW OF MEDICAL RECORD IS NOT APPLICABLE. NOT COMPATIBLE PRODUCT COMBINATION MIGHT BE A POTENTIAL ROOT CAUSE FOR THE REPORTED EVENT. HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. NO FURTHER ACTIONS HAVE BEEN INITIATED AS A RESULT OF THE REPORTED EVENT INVESTIGATION. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A REVISION SURGERY OF HIP REPLACEMENT, THE SURGEON ENCOUNTERED DIFFICULTIES WITH THE INSTALLATION OF THE JOINT BETWEEN THE HEAD AND THE LINER. INDEED, THE TWO ITEMS SLIDE APART VERY EASILY. THE SURGEON ELECTED TO IMMEDIATELY REVISE THE LINER AND HEAD. THESE ITEMS WERE EXPLANTED. THE SURGERY TOOK AROUND 25 MINUTES LONGER THAN EXPECTED DUE TO THE NEED TO REVISE THE IMPLANTED HEAD AND LINER.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED, SEE H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818806 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2895208 00889024430303

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male Hospitalization| R SEE H10 NARRATIVE