BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM

    MDR report key: 18928335 · Received March 19, 2024

    Report

    Report Number
    3002806535-2024-00104
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 20, 2024
    Report Date
    May 31, 2024
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271168
    PMA / PMN Number
    K192683
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 ¿ TPRLC 133 T1 PPS SO 20X160MM, ITEM# 51-103200, LOT#7244589. HXPE LINER NEUT 58 LL X 36, ITEM# 00-8751-013-36, LOT# 65501354. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT IDENTIFIED METAL TRANSFER TO THE CERAMIC HEAD WHICH COULD BE FROM BOTH THE DISLOCATION AND FROM THE INSTRUMENTS WHERE THE HEAD WAS ATTEMPTED TO BE REMOVED FROM THE STEM. THE HEAD IS STILL ATTACHED TO THE STEM. A REVIEW OF THE DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL SIMILAR COMPLAINTS FOR THIS ITEM NUMBER. IT SHOULD BE NOTED HOWEVER THAT PHYSICALLY THE SAME DEVICE IS INCLUDED IN AN ADDITIONAL COMPLAINT, AND REPORTED IN MFR 3002806535-2024-00105, WHERE THE HEAD COULD NOT BE REMOVED FROM THE STEM TAPER UPON REVISION AFTER THE DISLOCATION WHICH IS INVESTIGATED IN THIS COMPLAINT (DISLOCATION). RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A RADIOLOGIST. THE REVIEW IDENTIFIED THAT THERE IS A LEFT HIP ARTHROPLASTY WITH A SUPEROLATERAL DISLOCATION. THE FEMORAL HEAD IS ANTERIORLY DISPLACED ON THE CROSS-TABLE LATERAL VIEW, BUT THE CUP IS NOT WELL VISUALIZED. THERE IS NO FRACTURE. OTHER THAN THE DISLOCATION, NO OTHER IMPLANT FAILURE IS IDENTIFIED. THE CUP ABDUCTION ANGLE MEASURES APPROXIMATELY FIFTY-THREE DEGREES, AT THE UPPER LIMIT OF NORMAL. WITH THE AVAILABLE INFORMATION, A DEFINITIVE ROOT CAUSE COULD NOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION ON THE SAME DAY AS THE INITIAL IMPLANT DUE TO A POST-OP DISLOCATION. THE LINER AND HEAD WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REVISION ON THE SAME DAY AS THE INITIAL IMPLANT DUE TO A POST-OP DISLOCATION. THE HEAD AND STEM WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2277274 BIOLOX DELTA MODULAR CERAMIC FEM HD 36/-3MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER LZO BIOMET UK LTD. N/A 3159543 00887868271168

    Patients

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