BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 14787501 · Received June 23, 2022

    Report

    Report Number
    1818910-2022-11577
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    March 25, 2013
    Report Date
    June 23, 2022
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295009900
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT THE PRODUCT INVESTIGATION FOUND NO EVIDENCE SUSPECTING AN ERROR IN THE MANUFACTURING OR MATERIAL THAT WOULD BE A CONTRIBUTING FACTOR IN THE REPORTED ALLEGATION(S). A MANUFACTURING RECORDS EVALUATION (MRE) WAS NOT PERFORMED.

    Description of Event or Problem · 0

    INITIAL IMPLANT ON DATE (B)(6) 2022. MOBILIZATION OF THE PROSTHESIS AFTER IMPLANTATION: IN ADDITION METALLOSIS: MOLYBDENUM 3.8 UG/L, CR 66 UG/L; CO 95.5 UG/L, AL 7.85 UG/L. NEEDED REVISION SURGERY THAT TOOK PLACE AT CASA DI CURA VILLA BIANCO IN TRENTO DUE TO MECHANICAL LOOSENING OF THE JOINT PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761974 PINN CAN BONE SCREW 6.5MMX25MM BONE SCREWS AND PINS : SCREWS LPH DEPUY ORTHOPAEDICS INC US 1217-25-500 A1TE34000 10603295009900

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention ARTICULEZE M HEAD 36MM +12| PINN CAN BONE SCREW 6.5MMX25MM| PINN CAN BONE SCREW 6.5MMX30MM| PINNACLE MTL INS NEUT36IDX56OD| PINNACLE SECTOR II CUP 56MM| PROXIMA HI OFFSET L SZ 4