BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL STEM PRESS-FIT COLLARLESS 12/14TAPER EXTENDED NECK OFFSET SIZE 12 128 MM

    MDR report key: 9646388 · Received January 30, 2020

    Report

    Report Number
    0001822565-2020-00398
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    December 23, 2019
    Report Date
    February 5, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LPH
    UDI-DI
    00889024139244
    PMA / PMN Number
    K051491
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H1, H2, H3, H6, H10. CORRECTION: A1. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REPORTED EVENT WAS CONFIRMED BY REVIEW OF MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: PATIENT UNDERWENT A RIGHT THA, AND A PROPHYLACTIC CABLE WAS PLACED AROUND THE FEMUR DUE TO OSTEOPOROSIS,NO OTHER COMPLICATIONS WERE NOTED.AT A POST-OP VISIT A MONTH LATER, FEMUR FRACTURE AND MILD SUBSIDENCE OF THE STEM WERE NOTED, MILD PAIN WAS ALSO REPORTED.PATIENT IS UNDER OBSERVATION, NO TREATMENT YET. 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: G7 ACETABULAR SHELL PN: 010000662 LN: 6522380, G7 ACETABULAR LINER PN: 010000856 LN: 6598669, CERAMIC FEMORAL HEAD PN: 00877503602 LN: 3002562. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE LOCATION IS UNKNOWN.  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 THE PATIENT UNDERWENT A RIGHT TOTAL HIP ARTHROPLALSTY. AT THE ONE MONTH POST-OP VISIT IT WAS NOTED THE PATIENT HAD A FRACTURED FEMUR AND STEM SUBSIDENCE. NO INTERVENTION IS NOTED, JUST OBSERVATION. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NONE WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112165 FEMORAL STEM PRESS-FIT COLLARLESS 12/14TAPER EXTENDED NECK OFFSET SIZE 12 128 MM PROSTHESIS, HIP LPH ZIMMER BIOMET, INC. N/A 64180643 00889024139244

    Patients

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