BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CERAMIC FEM HD 36/+3MM

    MDR report key: 17570996 · Received August 18, 2023

    Report

    Report Number
    3002806535-2023-00280
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    February 15, 2023
    Report Date
    September 6, 2023
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LZO
    UDI-DI
    00887868271182
    PMA / PMN Number
    K200959
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10 - ASSOCIATED PRODUCTS: TPRLC 133 T1 PPS HO 17X154MM; ITEM# 51-104170; LOT# 7193590. G7 PPS LTD ACET SHELL 56F; ITEM# 010000665; LOT# 7516504. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH; ITEM# 00-6250-065-35; LOT# J6851903. BONE SCREW SELF-TAPPING 6.5 MM DIA. 25 MM LENGTH: ITEM# 00-6250-065-25; LOT# J6859885. 36MM I.D. SIZE F NEUTRAL LINER; ITEM# 20103606; LOT# 65224130. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. 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 AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H6, H10. 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. MEDICAL RECORDS (CRF REPORT) WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. THE PAIN WAS REPORTED AS RESOLVED APPROXIMATELY THREE MONTHS AGO WITHOUT MEDICAL INTERVENTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD AN INITIAL RIGHT HIP ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT STATED HAVING SHARP PAIN MID-THIGH WHEN STANDING AND WALKING EIGHT MONTHS POST IMPLANTATION. THE PAIN WAS REPORTED TO BE RESOLVED WITHOUT MEDICAL INTERVENTION. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    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
    2331208 DELTA CERAMIC FEM HD 36/+3MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS LZO BIOMET UK LTD. 3062847 00887868271182

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other SEE H10 NARRATIVE