BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/+3MM

    MDR report key: 17188892 · Received June 23, 2023

    Report

    Report Number
    3002806535-2023-00205
    Event Type
    Injury
    Date Received
    June 23, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 25, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271182
    PMA / PMN Number
    K192683
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. DEVICE IS USED FOR TREATMENT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. INITIAL IMAGING DEMONSTRATES A LOOSE FEMORAL IMPLANT WITH EXTENSIVE OSTEOLYSIS AND A NON-DISPLACED PROXIMAL FEMORAL CORTICAL FRACTURE. SUBSEQUENT TO THIS, REVISION WAS PERFORMED. THERE IS A DISLOCATION OF THE RIGHT HIP ARTHROPLASTY. EXTENSIVE RADIOLUCENCY ALONG THE PROXIMAL FEMORAL STEM IS PRESENT AS NOTED. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - 11-300916 ARCOS 16X190MM SPL TPR DIST 943100. 11-301353 ARCOS CON SZ C HI 80MM 590390. 00223200204 INTEGRAL SHORT GTR W/ 2 CABLES 56705650. 00625006550 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH 64084511. 00625006550 BONE SCREW SELF-TAPPING 6.5 MM DIA. 50 MM LENGTH J7307819. 00875201336 36MM I.D. SIZE LL ELEVATED RIM LINER USE WITH 58MM O.D. SIZE LL SHELL 64239463. 00875705802 58MM O.D. SIZE LL POROUS UNCEMENTED WITH MULTI-HOLES SHELL USE WITH LL LINERS 63290514. 31-323240 3.2MMX40MM RNGLC+ ACET DRL BIT 233750. 31-323260 3.2MMX60MM RNGLC+ ACET DRL BIT 597010. 310.250S DRILL BIT 2.5MM, L 110/85MM 2-FLUTE, F/QUICK COUPLING 9L85899 DEPUY. G2: FOREIGN - AUSTRALIA. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS IMPLANTED WITH NON-ZIMMER BIOMET PRODUCTS. THE NON-ZIMMER BIOMET PRODUCTS WERE REVISED FOR AN UNKNOWN REASON, AND THE PATIENT WAS IMPLANTED WITH THE ARCOS STEM. THE STEM WAS UNDERSIZED DUE TO AN IATROGENIC ERROR ON THE SURGEON¿S BEHALF DURING THE FIRST REVISION. ELEVEN DAYS POST IMPLANTATION THE PATIENT WAS REVISED DUE TO THE STEM UNDER SIZING AND DISLOCATION THAT OCCURRED DUE TO THE STEM UNDER SIZING. THERE WAS NO NEED TO ADJUST THE ACETABULAR SIDE AS IT REMAINED STABLE. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2214135 DELTA CERAMIC FEM HD 36/+3MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3062848 00887868271182

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.