BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR LAT FMRL 12.5X145

    MDR report key: 7745673 · Received August 2, 2018

    Report

    Report Number
    0001825034-2018-04474
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    August 21, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK030055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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. MEDICAL DEVICES: ITEM #US157858, CUP, LOT # 590680 ; ITEM # 139270, TAPER INSERT, LOT # 172460; ITEM # 157452, FEMORAL HEAD, LOT # 933620 . MULTIPLE REPORTS HAVE BEEN SUBMITTED FOR THIS EVENT. PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-03329, 0001825034-2018-03330, 0001825034-2018-04475.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 10 YEARS POST IMPLANTATION A PATIENT IS EXPERIENCING PAIN, ELEVATED ION LEVELS, AND A CLICKING SOUND. DURING A MEDICAL EXAM, THE PATIENT IDENTIFIED THE PAIN AS A 1 OUT OF 10 WITH ACHING AND CLICKING. THE SYMPTOMS WERE OF A GRADUAL ONSET OVER A PERIOD OF MONTHS. THE SYMPTOMS TEND TO BE INTERMITTENT, AND ARE AGGRAVATED BY PROLONGED STANDING. A PHYSICAL EXAMINATION PRESENTED NO TENDERNESS, BUT DID EXHIBIT MILD CLUNKING WITH LUMBAR AND HIP EXTENSION. IT WAS DIFFICULT TO DISTINGUISH FROM SOFT TISSUE SNAPPING. ABLE TO PERFORM FULL RANGE OF MOTION WITH NO PAIN OR SIGNS ON INTERNAL/EXTERNAL IMPINGEMENT. JOINTS APPEARED STABLE. MUSCLE STRENGTH IS SUPERIOR. THE RIGHT LOWER EXTREMITY APPEARS TO BE APPROXIMATELY 1 TO 2 CM SHORTER THAN THE LEFT. THE PATIENT HAS BEEN INDICATED FOR A REVISION, HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584429 TAPERLOC POR LAT FMRL 12.5X145 HIP PROSTHESIS LPH ZIMMER BIOMET, INC. N/A 175100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention