BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSYS HIP SYSTEM

    MDR report key: 15806908 · Received November 15, 2022

    Report

    Report Number
    MW5113312
    Event Type
    Injury
    Date Received
    November 15, 2022
    Date of Event
    November 23, 2020
    Report Date
    November 14, 2022
    Manufacturer
    ZIMMER, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REVISION SURGERY FOR FAILED LEFT TOTAL HIP ARTHROPLASTY WITH TRUNNIONOSIS AND RESULTANT METALLOSIS. FOLLOWING A METAL TOTAL HIP REPLACEMENT ON (B)(6) 2015. I EXPERIENCED A GRADUAL ONSET OF NEUROLOGICAL SYMPTOMS, WITH LEFT HIP, BUTTOCK AND LOWER BACK PAIN, RADIATING DOWN THE EXTREMITY. I 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 (B)(6) CLINIC IN (B)(6) 2020. 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 UNTIL (B)(6) 2021. 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". VERSYS HIP SYSTEM SURGERY INCLUDED: FEMORAL HEAD 12/14 TAPER, 32MM DIAMETER AND 10MM NECK LENGTH, LOT# 62847098, EDI (B)(4), REF 8018-32-02, FEMORAL STEM, LOT# 62833317, EDI (B)(4), REF 00-7864-013-00, 12/14 NECK TAPER STANDARD NECK OFFSET, SIZE 13, 138MM STEM LENGTH CEMENTLESS. TRILOGY ACETABULAR SYSTEM LINER LOT# 62842925, EDI (B)(4), REF 6305-50-32, BONE SCREW LOT 62825599 AND SHELL WITH CLUSTER HOLES POROUS LOT# 62779497. I WAS INFORMED THE REMOVED IMPLANTS WERE SENT TO (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2838607 VERSYS HIP SYSTEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER, INC. 62847098
    2838608 TRILOGY ACETABULAR SYSTEM LINER PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER, INC. 62833317
    2838609 FEMORAL STEM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH ZIMMER, INC 62825599, 62779497, 62842925

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Disability| H BABY ASPIRIN | DICLOFENAC| GABAPENTIN| PROBIOTIC | SAMBUCOL | TYLENOL| VITAMIN D3