BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACT ARTIC E1 HIP BRG 28X46MM

    MDR report key: 12173904 · Received July 15, 2021

    Report

    Report Number
    0001825034-2021-02111
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    May 22, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00880304485068
    PMA / PMN Number
    K161190
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: A2; A4; B5; B7; D6; G3; H2; H3; H6 D10: ITEM NUMBER 650-1065 ITEM NAME CER OPTION TYPE 1 TPRSLEVE -3 LOT # 3031054 ITEM NUMBER 650-1055 ITEM NAME CER BIOLOXD OPTION HD28MM LOT # 3050662 ITEM NUMBER UNK ITEM NAME UNK SHELL LOT # UNK ITEM NUMBER UNK ITEM NAME UNK TAPERLOC STEM LOT # UNK PRODUCT HAS BEEN RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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. CORRECTED: D6 IMPLANT DATE.    ONE ACT ARTIC E1 HIP BRG 28X46MM ITEM# EP-200152 LOT# 668880 WAS RETURNED AND EVALUATED. UPON VISUAL INSPECTION THE RETURNED BEARING HAD BEEN DEFORMED AND THERE WERE INDENTATIONS AROUND THE OD. THERE WAS A TAPER ALSO RETUNED THAT HAD DEBRIS AND A WEAR LINE VISIBLE. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. A REVIEW OF THE AVAILABLE RECORDS IDENTIFIED: EXTENSIVE WEAR OF THE BEARING, ATTEMPTED CLOSED REDUCTION, I&D OF PLASTIC DEBRIS, POPPING SENSATION THAT PROGRESSED TO DISLOCATION AS REPORTED, AND DIFFICULTY AMBULATING. A SMALL AMOUNT OF METALLOSIS WAS NOTED. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. 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 PRIMARY RIGHT THA WAS PLACED. SUBSEQUENTLY PATIENT EXPERIENCED PAIN, AND ELEVATED METAL IONS, AND UNDERWENT RIGHT THA REVISION OF HEAD TO DUAL MOBILITY CERAMIC INNER HEAD AND POLY E1 OUTER BEARING APPROXIMATELY TEN (10) YEARS POST IMPLANTATION. ADDITIONALLY ELEVEN (11) DAYS AFTER THE FIRST REVISION PATIENT UNDERWENT ORIF/REVISION DUE TO RIGHT THA DISLOCATION AND WAS FOUND DISASSOCIATION OF DUAL MOBILITY COMPONENTS, WITH IMPLANT WEAR, DEBRIS AND SMALL AMOUNT OF METALLOSIS WAS NOTED. 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: ITEM NUMBER 650-1065 ITEM NAME CER OPTION TYPE 1 TPRSLEVE -3 LOT # 3031054. ITEM NUMBER 650-1055 ITEM NAME CER BIOLOXD OPTION HD28MM LOT # 3050662. PRODUCT HAS BEEN 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 PATIENT UNDERWENT TOTAL HIP TOTAL HIP ARTHROPLASTY. SUBSEQUENTLY, SALES REP WAS CALLED IN FOR A TOTAL HIP DISLOCATION THE SAME DAY. UPON OPENING THE PATIENT IT WAS DISCOVERED THAT THE HEAD HAD DISASSOCIATED FROM THE BEARING. IT WAS DECIDED TO REVISE THE HEAD AND BEARING. AT THIS TIME WHAT APPEARED TO BE POLY SHAVINGS WERE INSIDE THE BEARING AND THE BEARING WAS DEFORMED AND SCRATCHED INSIDE AND OUT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074051 ACT ARTIC E1 HIP BRG 28X46MM PROSTHETIC, HIP LPH ZIMMER BIOMET, INC. N/A 668880 00880304485068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE