BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS

    MDR report key: 6397095 · Received March 10, 2017

    Report

    Report Number
    0001825034-2017-01436
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 7, 2017
    Report Date
    May 3, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK082446
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER POSSIBLE ADVERSE EFFECTS, 1. ¿MATERIAL SENSITIVITY REACTIONS.¿ PATIENT WAS BORN IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1825034-2017-01437. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 15-105050 M2A 38MM ONE PIECE CUP SZ 50MM 791560, 11-173664 M2A 38MM MOD HD+6MM NK 366610, UNKNOWN STEM. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE RETURNED MOD HEAD REVEALED FOREIGN DEBRIS IN THE TAPER HOLE. RETURNED CUP SHOWS FOREIGN BONE DEBRIS ON THE POROUS SURFACE.THE INDENTATIONS ON THE ARTICULATE SURFACE OF THE HEAD AND CUP ARE CONSISTENT WITH THE METAL-ON-METAL ARTICULATION DURING THE SERVICE LIFE. QUANTITATIVE EDS ANALYSIS OF THE DARK-IMAGING DEPOSITS WITHIN THE MORSE TAPER SHOWED COMBINATIONS OF: ¿BIOLOGICAL MATERIAL CONTAINING THE ELEMENTS C, O AND P ¿TITANIUM ALLOY CONTAINING THE ELEMENTS TI AND V (LIKELY TRANSFER FROM THE STEM TAPER) ¿C O, MO, FE, MN AND SI FROM THE MODULAR HEAD SUBSTRATE ¿ELEVATED LEVELS OF CR AND OFTEN MO (POSSIBLY OXIDIZED TAPER CORROSION PRODUCTS) THE REGION NEAR THE TAPER OPENING CONTAINED BIOLOGICAL MATERIAL CONTAINING C, O, P WITH MINOR TITANIUM TRANSFER. ELEMENTS FROM THE SUBSTRATE MATERIAL (CO, CR, MO, SI, FE, MN) WERE ALSO PRESENT, CONSISTENT WITH UNOXIDIZED ASTM F75 COCR MO ALLOY. A DARK IMAGING FEATURE DEEPER IN THE TAPER BORE WAS FOUND TO CONTAIN BIOLOGICAL MATERIAL CONTAINING THE ELEMENTS C, N, O, P, CA WITH MINOR TITANIUM TRANSFER. THIS REGION ALSO SHOWED SUBSTRATE MATERIAL (CO, CR, MO, SI, FE, MN) WITH ELEVATED CR AND MO LEVELS, POSSIBLY DUE TO CORROSION OF THE TAPER. EDS ANALYSIS OF THE MACHINED TAPER CHAMFER WAS CONSISTENT WITH ASTM F75 CAST COCR MO ALLOY. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S RIGHT HIP WAS REVISED 7 YEARS POST-IMPLANTATION DUE TO ADVERSE REACTION TO METAL DEBRIS (ARMD), DISCOMFORT AND ELEVATED METAL ION LEVELS. DURING THE PROCEDURE, THE FEMORAL HEAD AND ACETABULAR CUP WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION ON THE REPORTED EVENT, BUT NONE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177658 BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 791560

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R