BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RD118856

    MDR report key: 8785659 · Received July 12, 2019

    Report

    Report Number
    0001825034-2019-02935
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    October 10, 2017
    Report Date
    July 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A2; D1; D2; D4; D11; B7; G4; G5; H2; H3; H4; H6 D11: RD118856-M2A 38MMX56MM CUP-002630 103208-TAPERLOC POR FMRL 15X150-048260 REPORTED EVENT WAS CONFIRMED VIA REVIEW OF MEDICAL RECORDS/RADIOGRAPHS BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: (SUMMARIZED BY HCP), RIGHT HIP PAIN, POOR BONE QUALITY/OSTEOPENIA, EBL 300ML, MINIMAL METALLOSIS, AND MINIMAL FIBROUS TYPE TISSUE. SURGEON WENT TO PLACE NEW LINER, AND DID NOT FULLY SEAT, SURGEON COMMENTS HE COULD HAVE DAMAGED IT, ATTEMPTED NEW LINER AND PLACED WITHOUT ISSUES. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. 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

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION ON REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: PART: UNK, UNK M2A CUP, LOT: UNK; PART: UNK, UNK M2A STEM, LOT: UNK; PART: UNK, UNK M2A HEAD, LOT: UNK. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: HEAD: 0001825034-2019-02933, CUP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY AND SUBSEQUENTLY OVER THIRTEEN YEARS LATER THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO PAIN, DISCOMFORT, LACK OF MOBILITY, LIMITED ACTIVITIES OF DAILY LIVING, AND ELEVATED METAL ION. ALL COMPONENTS REVISED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577725 RD118856 PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 002630

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10