BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM 12/14 NECK TAPER PLASMA

    MDR report key: 10739493 · Received October 27, 2020

    Report

    Report Number
    0001822565-2020-03633
    Event Type
    Injury
    Date Received
    October 27, 2020
    Date of Event
    July 20, 2020
    Report Date
    December 11, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    K192660
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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: B4, B5, D4, G4, H2, H3, H4, H6 REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL. PATIENT UNDERWENT AN INITIAL R THA DUE TO OA. NOTED DISCREPANCY IN LIMB LENGTH, RIGHT LEFT 4MM SHORTER THAN LEFT. NO INTRAOPERATIVE COMPLICATIONS NOTED. FIRST THREE FOLLOW UPS IDENTIFIED EQUAL LIMB LENGTHS AND NO PAIN. FOLLOW UP IDENTIFIED PAIN AS 2/10, XRAY IDENTIFIED GOOD ALIGNMENT AND NO EVIDENCE OF LOOSENING, IMPRESSION OF TROCHANTERIC BURSITIS. KENALOG INJECTION GIVEN. ANOTHER FOLLOW UP IDENTIFIED PAIN INCREASE TO 3/10 WITH PERIODS OF IMMOBILITY AND DISCOMFORT WHEN BEGINNING TO AMBULATE. XRAYS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. 1 OF THE 3 IMAGES DOES NOT PROVIDE FULL VIEW OF STEM. IMAGES WILL NOT BE SUBMITTED AS THE OFFICE RECORDS INDICATE PATIENT IS EXPERIENCING BURSITIS OF RIGHT HIP. DEVICE HISTORY RECORD (DHR) 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). CONCOMITANT MEDICAL PRODUCTS: CAT# 00877502802 BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 28/0, TAPER 12/14 LOT# 299092. CAT# 110010246 G7 OSSEOTI 4 HOLE SHELL 56MM F LOT# 6492270. CAT# 110024464 G7 DUAL MOBILITY LINER 44MM F LOT# 424190. CAT# EP-200150 ACT ARTIC E1 HIP BRG 28X44MM LOT# 791850. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS, AS THE DEVICE REMAINS IMPLANTED; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2020-03886, 0001825034-2020-03887, 0001825034-2020-03888.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN INITIAL RIGHT TOTAL HIP ARTHROPLASTY PERFORMED APPROXIMATELY ONE YEAR AGO. AT THE ONE-YEAR VISIT, THE PATIENT REPORTED MODERATE PAIN AND A NEW ONSET LIMP. NO INTERVENTION OR FURTHER COMPLICATIONS NOTED AT THIS TIME. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204165 FEMORAL STEM 12/14 NECK TAPER PLASMA PROSTHESIS, HIP LZO ZIMMER BIOMET, INC. N/A 64172550

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other