BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DLT TS CER HD 12/14 36MM +12

    MDR report key: 10483930 · Received September 2, 2020

    Report

    Report Number
    1818910-2020-19288
    Event Type
    Injury
    Date Received
    September 2, 2020
    Date of Event
    April 21, 2010
    Report Date
    August 18, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LZO
    UDI-DI
    10603295033684
    PMA / PMN Number
    K071830
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. CORRECTIVE ACTION WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. FOLLOW-UP IS BEING CONDUCTED TO DETERMINE INITIAL REPORTER CONTACT INFORMATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE PATIENT WAS ORIGINALLY AN ASR PATIENT IMPLANTED (B)(6) 2007 AND REVISED ON (B)(6) 2009 TO PINNACLE PRODUCTS AND HAS SINCE BEEN REVISED TO FURTHER PINNACLE PRODUCTS AND THESE HAVE ALSO BEEN REVISED. ASR SURGERY: ASR XL IMPLANTED (B)(6) 2007. ASR REVISED (B)(6) 2009 ¿ STEM REMAINED IN SITU. 1ST PINNACLE SURGERY: PINNACLE CUP, HEAD, LINER IMPLANTED (B)(6) 2009. ACETABULAR CUP PINNACLE MULTIHOLE 58 REF: 1217-20-058. CERAMIC FEMORAL HEAD REF: 1365-35-740. METAL INSERT PINNACLE REF: 121887358. PINNACLE CUP, HEAD, LINER REVISED (B)(6) 2010 - STEM REMAINED IN SITU. REASON FOR REVISION: PAIN, DISLOCATION OF IMPLANT. UPDATE AD 18 AUG 2020: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO CLAIMSUITE ALERTS RECEIVED. CLAIMSUITE ALERT ALLEGES ACETABULAR & FEMORAL COMPONENT LOOSENING. ADDED ASSOCIATED CONTACT, PATIENT HARM AND CONCOMITANT PRODUCTS. DOI: (B)(6), "200" - DOR: (B)(6), 2010 (LEFT HIP). (B)(4) 1ST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946883 DLT TS CER HD 12/14 36MM +12 ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS LZO DEPUY ORTHOPAEDICS INC US 1365-36-740 2619799 10603295033684

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DLT TS CER HD 12/14 36MM +12| PINNACLE MTL INS NEUT36IDX58OD| PINNACLE MULTIHOLE II CUP 58MM| UNKNOWN HIP FEMORAL STEM