BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX DELTA CERAMIC TAPER LINER JJ / 36

    MDR report key: 15346571 · Received September 2, 2022

    Report

    Report Number
    0009613350-2022-00443
    Event Type
    Injury
    Date Received
    September 2, 2022
    Date of Event
    August 19, 2022
    Report Date
    September 30, 2022
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024429918
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). REPORT SOURCE-FOREIGN-CHINA. CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: 54MM O.D. SIZE JJ POROUS UNCEMENTED WITH CLUSTER HOLES SHELL USE WITH JJ LINERS; ITEM#: 00875305401; LOT#: 65417695. ITEM NAME: BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH; ITEM#: 00625006525; LOT#: 65193843. ITEM NAME: FEMORAL STEM 12/14 NECK TAPER PLASMA SPRAYED PRESS-FIT CEMENTLESS SIZE 9 STANDARD OFFSET REDUCED NECK LENGTH; ITEM#: 00771100910; LOT#: 65016722; ITEM NAME: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14; ITEM#: 00877503603; LOT#: 3041356. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4). 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. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. X-RAYS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED ABNORMAL PLACEMENT OF THE CERAMIC LINER OF THE ACETABULAR CUP WHICH APPEARS SEPARATED FROM THE CUP AND LOCATED ADJACENT TO THE MEDIAL PORTION OF THE FEMORAL HEAD HARDWARE COMPONENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CERAMIC LINER. THE CERAMIC LINER CAME OUT POST SURGERY. THE PATIENT UNDERWENT REVISION SURGERY THE NEXT DAY, WHERE A NEW CERAMIC LINER WAS INSERTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538066 BIOLOX DELTA CERAMIC TAPER LINER JJ / 36 HIP PROSTHESIS LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3052861 00889024429918

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Prefer Not To Disclose Required Intervention| H SEE H10 NARRATIVE.