BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14

    MDR report key: 12090127 · Received June 30, 2021

    Report

    Report Number
    0009613350-2021-00318
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    April 22, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024430297
    PMA / PMN Number
    K071535
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    1. EVENT DESCRIPTION: IT WAS REPORTED THAT THE ARTICULATION BEARING OF THE G7 DUAL MOBILITY WAS IMPLANTED ON (B)(6) 2020 AND HAS DISLODGED FROM THE HEAD COMPONENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. HARM: S3- INSTABILITY, MODERATE HAZARDOUS SITUATION: IMPLANT COMPONENTS ARE DISSOCIATED IN THE PATIENT. 2. 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. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. 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. 5. CONCLUSION: IT WAS REPORTED THAT THE ARTICULATION BEARING OF THE G7 DUAL MOBILITY WAS IMPLANTED ON JANUARY 27, 2020 AND HAS DISLODGED FROM THE HEAD COMPONENT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021. 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). BASED ON THE SIGNIFICANT LACK OF INFORMATION THE REPORTED EVENT CANNOT BE CONFIRMED. 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

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: ACT ARTIC E1 HIP BRG 28X44MM; CATALOG#: EP-200150; LOT#: 242140. G7 OSSEOTI MULTIHOLE 54MM F; CATALOG#: 110010265; LOT#: 6616916. G7 DUAL MOBILITY LINER 44MM F; CATALOG#: 110024464; LOT#: 395650. FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 1 130 MM STEM LENGTH; CATALOG#: 00-8114-001-10; LOT#: 64543711. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. 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 INTRA-PROSTHETIC DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992708 BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2993731 00889024430297

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R