BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER

    MDR report key: 12108852 · Received July 2, 2021

    Report

    Report Number
    0001822565-2021-01793
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    August 18, 2020
    Report Date
    September 1, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024131811
    PMA / PMN Number
    K192660
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING:PRIMARY OP NOTES WERE REVIEWED AND NO COMPLICATIONS ARE NOTED. MEDICAL OP NOTES WERE REVIEWED AND THE FOLLOWING WERE IDENTIFIED. FOLLOW UP: PATIENT REPORTS SWEATING A LOT DURING SLEEP, STOPPED USING CANE 2 DAYS AFTER SURGERY, DOES NOT NEED TO USE WALKER, NO COMPLICATIONS ON EXAM. CRF FOLLOW UP MODERATE PAIN/PROBLEMS, PAIN 6/10, DISSATISFIED FOLLOW UP FEVER OF 101 LAST NIGHT BUT WOKE UP WITHOUT A FEVER, LEFT HIP PAIN INCREASED. X-RAY REVEALS COMPONENTS IN SATISFACTORY POSITION, NO EVIDENCE OF LOOSENING, SUBSIDENCE, WEAR. SURGEON STATES I BELIEVE HIS SETBACK IS DUE TO HIM MOUNTAIN BIKING THE DAYS PRIOR. HE SEEMS TO HAVE OVERDONE IT. A WEEK AGO TODAY, HE WOKE UP WITH A FEVER AND HAD SOME HIP PAIN. HE HAD ONE DAY OF FEVER. HE HAD NOT HAD ANY SINCE THAT TIME. GROIN PAIN IMPROVING, STILL HAVING SOME CALF PAIN, PATIENT HAS BEEN VERY ACTIVE BIKING AND WALKING ASPIRATION PERFORMED, CLEAR BLOODY FLUID RETURNED, SENT FOR CULTURES AND LABS TO RULE OUT INFECTION. NO RESULTS PROVIDED OR FURTHER TREATMENT NOTED IN CRF; THEREFORE INFECTION LIKELY RULED OUT AND THEREFORE NOT CALLED OUT OR NEW COMPLAINT REQUIRED DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE OF THE EVENT COULD NOT 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL DEVICES: PART # 00875706201/ SHELL WITH CLUSTER/ LOT # 64531316; PART # 00885101536/ NEUTRAL LINER/ LOT # 63303250; PART # 00877503603/ BIOLOX® DELTA, HEAD/ LOT # 3013399.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A LEFT HIP REVISION SURGERY 3 MONTHS¿ POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE. 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
    1006265 FEMORAL STEM 12/14 NECK TAPER PROSTHESIS HIP LPH ZIMMER BIOMET, INC. NI 64430556 00889024131811

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R SEE H10.