BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP IMPLANT

    MDR report key: 11796375 · Received May 10, 2021

    Report

    Report Number
    0009613350-2021-00204
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    December 3, 2020
    Report Date
    September 22, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH HIP PROSTHESIS ON (B)(6) 2010. POST IMPLANTATION PATIENT STARTED EXPERIENCING CONSIDERABLE AND PERSISTENT HEALTH PROBLEMS SO PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER ""DUE DILIGENCE"" REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DOCUMENT REVIEW COULD NOT BE PERFORMED DUE TO UNKNOWN PRODUCT IDENTIFICATION. DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATION. DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH HIP PROSTHESIS ON (B)(6) 2010. POST IMPLANTATION PATIENT STARTED EXPERIENCING CONSIDERABLE AND PERSISTENT HEALTH PROBLEMS SO PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2020. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NONCONFORMANCE OR COMPLAINT OUT OF BOX (COOB). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    NO EVENT UPDATE. INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON THE RIGHT SIDE AND UNDERWENT A REVISION SURGERY DUE TO UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693278 UNKNOWN HIP IMPLANT HIP PROSTHESIS LPH ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R