BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPERLOC POR RED/DIST 13.5X147

    MDR report key: 8101089 · Received November 26, 2018

    Report

    Report Number
    0001825034-2018-10862
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    November 13, 2012
    Report Date
    April 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    PMA / PMN Number
    K921301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS CONFIRMED BY REVIEW OF INITIAL AND REVISION OP NOTES AND MULTIPLE OFFICE VISIT NOTES PROVIDED. PRIMARY OP NOTES CONFIRMS NO COMPLICATIONS WERE NOTED. REVISION OP NOTES CONFIRM NO COMPLICATIONS WERE NOTED. OFFICE VISIT (B)(6) 2012 ¿ STILL SUFFERING SCIATIC PAIN. MRI ORDERED. PA GLIDE IS QUITE UNCOMFORTABLE AT THE 3-L4 BUT MOSTLY AT THE L4-L5 AND L5-S1. BUT LOWER QUADRANT LOADING BOTHERS HIM AT THE L4-L5 AND L5-S1. LEFT LOWER EXTREMITY RADICULITIS L4-L5 DISTRIBUTION. FACETOGENIC PAIN WITH DEGENERATIVE DISC DISEASE. MYOFASCIAL LUMBOSACRAL PAIN. SACROLITIS. OFFICE VISIT (B)(6) 2012 ¿ CONTINUES TO COMPLAIN OF SCIATIC PAIN. SCHEDULED FOR EPIDURAL INJECTION. OFFICE VISIT (B)(6) 2012 ¿ PATIENT STILL HAVING SOME GROIN PAIN. HE IS GETTING BETTER. HE IS ON MUCH LESS PAIN MEDICATION. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO 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). MEDICAL DEVICES: 54ODX48ID MAGNUM ABX PF CUP #US157854 LOT 072830; 32MM MOD HEAD COCR -6MM NECK # 163667 LOT 196450. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-10860 AND 0001825034-2018-10861. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUDDEN SHARP/STABBING IN THE BUTTOCK AREA OF THE PATIENT, GOING DOWN AND THREW THE ILIOTIBIAL BAND A LITTLE BIT IS INSIDE THE INCISION AREA, THEN TRANSVERSES DOWN THROUGH THE LATERAL HAMSTRING ALL THE WAY TO THE CALF AND TOP OF FOOT. PATIENT REPORTS CONTINUED PAIN REQUIRING PRESCRIPTION MEDICATION. REPORTS HIP CATCHES AND HAS INCREASED PAIN WITH LENGTHY AMBULATION, RECEIVED STEROID INJECTION TO HIP. PAIN IS REPORTED FOR THE 2 YEARS POST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942828 TAPERLOC POR RED/DIST 13.5X147 PROSTHESIS HIP LPH ZIMMER BIOMET, INC. N/A 534610

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other