BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD +0X32MM DIA

    MDR report key: 10108344 · Received June 2, 2020

    Report

    Report Number
    0002648920-2020-00280
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    August 21, 2020
    Report Date
    March 8, 2022
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11: MODULAR FEMORAL STEM CAT#00771300600 LOT#61713171. KINECTIV MODULAR NECK P CAT#00784801300 LOT#61813842. CONTINUUM TM SHELL CLUST 48 GG CAT#00875704801 LOT#61797510. HXPE LINER NEUT 48 GG X 32 CAT#00875100832 LOT#61785540. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, DUE TO LOCATION OF DEVICE IS UNKNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: UPDATED: B4, B5, G4, H2, H3, H6. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING : THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL HIP ARTHROPLASTY DUE TO DEGENERATIVE ARTHRITIS. THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO FAILED HIP ARTHROPLASTY. THE PATIENT HAD ELEVATED COBALT LEVELS - COBALT 2.0H UG/L RANGE <=1.0 UG/L. THE PATIENT WAS SUFFERING FROM PAIN, DECREASE IN ADLS AND AMBULATORY TOLERANCE. DURING THE PROCEDURE, CORROSION WAS NOTED AT THE HEAD-NECK JUNCTION. FEMORAL COMPONENT WEAR, SYNOVITIS, AND OSTEOLYSIS WERE PRESENT. THE SOFT TISSUES EXHIBITED METALLOSIS REACTION AND A PSEUDOCAPSULE WAS EXCISED. AFTER THE REVISION, DESIRED STABILITY, RANGE OF MOTION, AND ALIGNMENT WERE ACHIEVED. NO OTHER FINDINGS/ COMPLICATIONS RELATED TO THE EVENT WERE NOTED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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

    IT WAS REPORTED PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY NINE YEARS POST IMPLANTATION DUE TO DECREASE IN ACITVITY OF DAILY LIVING (ADL), , PSEUDOCAPSULE, IN-VIVO CORROSION, AND METALLOSIS. DURING THE PROCEDURE IT WAS NOTED THAT THERE WAS SYNOVITIS WITH FLUID COLLECTION AND THERE WAS FRETTING AT THE HEAD/TAPER JUNCTION WITH SOFT TISSUE REACTION. THE SURROUNDING SOFT TISSUES EXHIBITED TYPICAL METALLOSIS WEAR REACTION. CORROSION, FRETTING, AND WEAR REACTION WERE NOTED ON THE FEMORAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). REP NOTED THE REVISION CASE CANCELLED. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN ZIMMER M/L TAPER STEM, UNKNOWN ZIMMER KINECTIV NECK, UNKNOWN ZIMMER LINER, UNKNOWN ZIMMER CUP. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565-2020-01905, 0001822566-2020-01904.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS BEING CONSIDERED FOR A LEFT HIP REVISION PROCEDURE APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO UNKNOWN REASONS. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575995 FEMORAL HEAD +0X32MM DIA PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61864036
    575998 FEMORAL HEAD +0X32MM DIA PROSTHESIS, HIP LPH ZIMMER MANUFACTURING B.V. N/A 61864036

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R| O