BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UHR BIPOLAR 26X46MM

    MDR report key: 6953137 · Received October 16, 2017

    Report

    Report Number
    0002249697-2017-03025
    Event Type
    Injury
    Date Received
    October 16, 2017
    Date of Event
    September 18, 2017
    Report Date
    December 8, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K800207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION DUE TO PAIN INVOLVING A UHR BIPOLAR WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION OF RETURNED DEVICE INDICATED THAT MINOR SCRATCHES ARE OBSERVED ON DEVICE. MEDICAL RECORDS RECEIVED AND EVALUATION: MATERIAL ANALYSIS IS NOT PERFORMED AS THE REPORTED EVENT DOES NOT RELATE TO THE MATERIAL INTEGRITY OF THE DEVICE. DEVICE HISTORY REVIEW: A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. COMPLAINT HISTORY REVIEW: A COMPLAINT HISTORY REVIEW COULD NOT BE PERFORMED AS NO LOT INFORMATION WAS PROVIDED. CONCLUSIONS: IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PATIENT HIP BECAME PAINFUL. VISUAL INSPECTION OF RETURNED DEVICE INDICATED THAT MINOR SCRATCHES ARE OBSERVED ON DEVICE. MATERIAL ANALYSIS IS NOT PERFORMED AS THE REPORTED EVENT DOES NOT RELATE TO THE MATERIAL INTEGRITY OF THE DEVICE. FURTHER INFORMATION SUCH AS PRE- AND POST-OP X-RAYS, OFFICE NOTES, OPERATIVE REPORTS, PATIENT HISTORY, HISTOPATHOLOGY REPORT & FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: C-TAPER COCR LFIT HEAD 26MM/+5; CAT# 06-2605; LOT# MKEY2M, SIMPLEX P WITH TOBRAMYCIN 1 PACK; CAT# 6197-9-001; LOT# MLS094, SIMPLEX P WITH TOBRAMYCIN 1 PACK; CAT# 6197-9-001; LOT# MKT103, OMNIFIT HFX HIP STEM SIZE #08 132; CAT# 6070-0830A; LOT# MLTJDP, OSTEONICS UNIV. DISTAL SPACER; CAT# 1067-0011; LOT# MLT2MK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. REVIEW OF THE PRODUCT HISTORY RECORDS INDICATE THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    NO EVENT, HIP BECAME PAINFUL. PATIENT WAS REVISED, OPERATIVE SIDE NOT REPORTED.

    Description of Event or Problem · 1

    NO EVENT, HIP BECAME PAINFUL. PATIENT WAS REVISED, OPERATIVE SIDE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731152 UHR BIPOLAR 26X46MM PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH MLR96A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R