BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD +0X32MM DIA

    MDR report key: 12196039 · Received July 20, 2021

    Report

    Report Number
    0001822565-2021-01976
    Event Type
    Injury
    Date Received
    July 20, 2021
    Date of Event
    January 28, 2021
    Report Date
    January 9, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K953337
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D10: CAT#00-7864-013-00 LOT# 62833317 STEM, CAT#00-6305-050-32 LOT#62842925 LINER, LOT#62779497 SHELL, LOT#62825599 SCREW.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04)- HEAD. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ADDITIONAL INFORMATION DOES NOT CHANGE THE ROOT CAUSE OF THE INITIAL INVESTIGATION. 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 THE PATIENT UNDERWENT A LEFT HIP PROCEDURE. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO METALLOSIS, AND ELEVATED ION LEVELS, A GRADUAL ONSET OF NEUROLOGICAL SYMPTOMS, WITH LEFT HIP, BUTTOCK AND LOWER BACK PAIN, RADIATING DOWN THE EXTREMITY, SUBSEQUENTLY DEVELOPED A MYLAR (BUTTERFLY) RASH, BURNING THROAT AND EARS, BLURRY VISION, HEARING AND MEMORY IMPAIRMENT, TOOTH BREAKDOWN, MOUTH SORES WITH RESIDUAL PAIN, NUMBNESS IN LIPS, HANDS, SWOLLEN FINGERS WITH IMPAIRED GRASP, LOSS OF BALANCE, FATIGUE AND DYSPHORIA. A BLOOD TEST FOR METAL IONS WAS CONDUCTED THROUGH THE CLINIC IN RESULTS CONFIRMED TOXIC LEVELS OF COBALT AND CHROMIUM, AND ELEVATED LEVELS OF TITANIUM. AN EMERGENCY REVISION SURGERY WAS RECOMMENDED. DUE TO COVID PRECAUTIONS THE REVISION WAS DELAYED. OPERATIVE FINDINGS INDICATED CLEAR EVIDENCE OF TRUNNIONOSIS WITH BLACKENING OF THE TRUNNION. SUBSEQUENT PATHOLOGY REPORTS DESCRIBE PROSTHETIC WEAR DEBRIS REACTION INCLUDING GRANULOMATOUS RESPONSE TO METAL PARTICLES. NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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: 0001822565-2021-01977.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A LEFT HIP REVISION APPROXIMATELY 6 YEARS POST IMPLANTATION DUE TO PAIN, METALLOSIS, AND ELEVATED ION LEVELS. CORROSION OF THE TRUNION WAS ALSO NOTED. IT WAS ALSO REPORTED BEFORE THE REVISION, PATIENT SUFFERED FROM HEARING LOSS, PAIN IN THE LOWER BACK, BURNING SENSATION, PAIN IN THE EARS, MOUTH ISSUES, NUMBNESS AND TIREDNESS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095567 FEMORAL HEAD +0X32MM DIA PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 62847098

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Hospitalization| R HIP-STEM-UNKNOWN.| SEE H10 NARRATIVE.| HIP-STEM-UNKNOWN-