BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER

    MDR report key: 8649285 · Received May 29, 2019

    Report

    Report Number
    0002648920-2019-00337
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    May 6, 2019
    Report Date
    September 9, 2020
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D11: 00620005422 ¿ TRILOGY CUP ¿ 62845919; 00625006535 ¿ BONE SCREW - 62964047. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS NOTING THAT PATIENT HAD ADVERSE LOCAL TISSUE REACTION SECONDARY TO TRIBOCORROSION STATUS POST RIGHT HIP TOTAL ARTHROPLASTY. A PSEUDOTUMOR FILLED WITH FLUID WAS NOTED ALONG WITH CORROSION PRESENT INSIDE THE HEAD AND STAINING ON THE FEMORAL NECK. OSTEOLYSIS AROUND THE RIM OF THE SHELL WAS FOUND HOWEVER THE SHELL WAS WELL FIXED AND IN GOOD POSITION. THERE WAS MILD PROXIMAL OSTEOLYSIS AROUND THE FEMORAL COMPONENT WHICH WAS DEBRIDED AWAY. ADDITIONAL INFORMATION DOES NOT CHANGE THE OUTCOME OF THE PREVIOUS INVESTIGATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2020-00402. 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

    CONCOMITANT MEDICAL PRODUCTS: CATALOG#: 00630505032 50/52/54X32 STD TRILOGY LINER LOT#: 62954854, CATALOG#: 0106010104 AVENIR® MüLLER, STEM, LATERAL, UNCEMENT, HA, 4, TAPER 12/14 LOT#: 4021833. THE EVENT WAS CONFIRMED WITH PHOTOGRAPHS PROVIDED AND DEVICE RETURNED. EXAMINATION OF PHOTOGRAPHS PROVIDED, IDENTIFIED DISCOLORATION ON THE TAPER SURFACE OF THE STEM AND HEAD. NO FURTHER EVALUATION WAS POSSIBLE WITH THE IMAGES PROVIDED. VISUAL EXAMINATION OF PRODUCT RETURNED IDENTIFIED DARK DEBRIS AND THREAD LIKE PATTERN ON THE CONICAL TAPER. DIMENSIONAL ANALYSIS CONFIRMED THAT THE PRODUCT IDENTIFIERS WERE CONFORMING TO PRINT SPECIFICATIONS. DAMAGE IN THE FORM OF A GROOVE OR GOUGE WAS OBSERVED ON THE TAPER. NO OTHER ISSUES WERE IDENTIFIED. SEM ANALYSIS REVEALED DEPOSITS ON THE TAPER SURFACE AND CIRCUMFERENTIAL GROOVES, POSSIBLE FROM THE IMPRINTING OF THE SURFACE TEXTURE OF THE STEM TAPER. AXIAL WEAR OR CORROSION MARKS WITH LIGHT SURFACE PITTING AND ETCHING WERE ALSO OBSERVED ON THE TAPER'S SURFACE. QUANTITATIVE EDS OF THE TAPER'S SURFACE IDENTIFIED BIOLOGICAL MATERIAL CONTAINING SOME OR ALL OF C, O, AND P. COCRMO SUBSTRATE MATERIAL SHOWING ELEVATED LEVELS OF CR, MO, AND O, POSSIBLY EVIDENCE OF CORROSION PRODUCTS, AND TITANIUM, POSSIBLY TRANSFERRED FROM THE STEM TAPER WERE ALSO NOTED. RADIOGRAPHS WERE PROVIDED AND IDENTIFIED THE FOLLOWING : THE RIGHT HIP ARTHROPLASTY COMPONENTS WERE ANATOMICALLY ALIGNED. NO ISSUES WERE NOTED. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. 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

    IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY 4 YEARS POST IMPLANTATION DUE TO ELEVATED METAL ION LEVELS, PSEUDOTUMOR, ALTR, IN-VIVO CORROSION AND OSTEOLYSIS. THE HEAD AND LINER WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 50/52/54X32 STD TRILOGY LINER # ITEM 6305-50-32 LOT 62954854. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT HIP REVISION APPROXIMATELY EIGHT YEARS POST INITIAL SURGERY DUE TO A PSEUDO TUMOR. THE LINER AND COCR HEAD WERE REMOVED. THE LINER WAS DAMAGED UPON REMOVAL. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442513 FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER PROSTHESIS HIP LPH ZIMMER MANUFACTURING B.V. N/A 62971087

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R