BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC TAPER LINER, SIZE LL / 36 I.D

    MDR report key: 19552223 · Received June 17, 2024

    Report

    Report Number
    0009613350-2024-00240
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 27, 2024
    Report Date
    August 23, 2024
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    UDI-DI
    00889024429932
    PMA / PMN Number
    K192416
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ITEM# 00875705801 LOT# 63640013 58MM O.D. SIZE LL POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH LL LINERS . ITEM# 00625006530 LOT# 63535924 BONE SCR 6.5X30 SELF-TAP. ITEM# 00625006540 LOT# 63214016 BONE SCR 6.5X40 SELF-TAP. ITEM# 11300816 LOT# 124690 ARCOS 16X150MM SPL TPR DIST. ITEM# 11301304 LOT# 213170 ARCOS CON SZ D STD 60MM. ITEM# 6500661 LOT# 2017050061 DELTA CERAMIC FEM HD 36/0MM. G2: FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: G3; H2; H3; H6 CORRECTED: H6 - HEALTH EFFECT - CLINICAL CODE NO PRODUCT WAS RETURNED. VISUAL EXAMINATION OF THE PROVIDED PICTURES SHOWS THE LINER RIGHT AFTER THE REVISION. THE DEVICE IS STILL BLOODY. SOME SCRATCHES CAN BE SEEN ON THE LINER. A REVIEW OF ALL RELEVANT DEVICE MANUFACTURING RECORDS CONFIRMED NO ABNORMALITIES OR DEVIATIONS. REVIEW OF THE COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED COMPLAINTS FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. ONE X-RAY PICTURE WAS PROVIDED AND REVIEWED BY A RADIOLOGIST. RIGHT HIP ARTHROPLASTY COMPONENTS ARE ANATOMICALLY ALIGNED. THERE IS NO ACUTE OSSEOUS ABNORMALITY. THE DEVICE HAS NOT BEEN RECEIVED; THEREFORE, THE CONDITION OF THE COMPONENT REMAINS UNKNOWN. PATIENT FACTORS THAT MAY HAVE AFFECTED THE PERFORMANCE OF THE COMPONENTS SUCH AS ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. IF AND TO WHAT EXTENT OTHER POSSIBLE FACTORS MIGHT HAVE BEEN INVOLVED ALSO REMAINS UNKNOWN. 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 HAD A REVISION SURGERY DUE TO NOISE, APPROXIMATELY SEVEN (7) YEARS AFTER IMPLANTATION. THERE WAS REPRODUCIBLE AUDIBLE SQUEAKING AND CREPITUS BY THE PATIENT. SCANS SHOWED POOR ALIGNMENT OF THE ACETABULAR COMPONENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332159 BIOLOX DELTA CERAMIC TAPER LINER, SIZE LL / 36 I.D BIOLOX HIP PROSTHESIS LZO ZIMMER GMBH N/A 2738375 00889024429932

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11 NARRATIVE.