BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIFLEX M-HA HIP STEM

    MDR report key: 11035864 · Received December 18, 2020

    Report

    Report Number
    0002249697-2020-02703
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    November 25, 2020
    Report Date
    January 27, 2021
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    KWL
    PMA / PMN Number
    K920193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PERIPROSTHETIC FRACTURE INVOLVING A OMNIFIT STEM WAS REPORTED. THE EVENT WAS CONFIRMED VIA MEDICAL REVIEW. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS NOTE THE FOLLOWING: PHOTOS SHOW A RECENTLY EXPLANTED DEVICE WITH BIOLOGICAL MATERIAL THROUGHOUT. THERE ARE NO REMARKABLE OBSERVATIONS TO NOTE. CLINICIAN REVIEW: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: RE PI - WHICH REPRESENTS A MALE PATIENT, DOB (B)(6) 1936 DESCRIBED AS 60 INCHES TALL AND WEIGHING 120 POUNDS. HIS DATE OF IMPLANTATION IS LISTED AS (B)(6) 1995 APPROX. AND EXPLANTATION (B)(6) 2020. THE EVENT DESCRIPTION STATES: "... REVISION ... PERIPROSTHETIC FRACTURE OF A 25 YEAR OLD HEMIARTHROPLASTY ..." UNDATED X-RAY: AP HIP SIDE NOT MARKED UNCEMENTED OMNIFLEX HEMIARTHROPLASTY, REDUCED, WITH COMMINUTED PERIPROSTHETIC FRACTURE OF PROXIMAL FEMUR. (B)(6) 2020 IMPLANT LABELS: 9 DALL-MILES CABLE AND SLEEVE SETS, SMALL DALL-MILES TROCHANTERIC GRIP, 195/17 RESTORATION MODULAR STEM, 21/@0 V-40 BODY, (B)(4) V-40 LFIT HEAD, 40/26 UHR BIPOLAR. NO CLINICAL OR PMH,NO DATED SERIAL X-RAYS, NO OPERATIVE REPORTS, NO EXAMINATION OF EXPLANTED COMPONENTS. WHILE THE SUBMITTED X-RAY APPEARS TO CONFIRM THE EVENT DESCRIPTION, INSUFFICIENT DATA IS PRESENTED TO CREATE A MEDICAL REPORT FOR THIS CASE. PRODUCT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. COMPLAINT HISTORY REVIEW: COULD NOT BE PERFORMED AS LOT CODE INFORMATION WAS NOT PROVIDED. CONCLUSIONS: A REVIEW OF THE PROVIDED MEDICAL INFORMATION BY A CLINICAL CONSULTANT INDICATED: RE PI - WHICH REPRESENTS A MALE PATIENT, DOB (B)(6) 1936 DESCRIBED AS 60 INCHES TALL AND WEIGHING 120 POUNDS. HIS DATE OF IMPLANTATION IS LISTED AS (B)(6) 1995 APPROX. AND EXPLANTATION (B)(6) 2020. THE EVENT DESCRIPTION STATES: "... REVISION ... PERIPROSTHETIC FRACTURE OF A 25 YEAR OLD HEMIARTHROPLASTY ..." UNDATED X-RAY: AP HIP SIDE NOT MARKED UNCEMENTED OMNIFLEX HEMIARTHROPLASTY, REDUCED, WITH COMMINUTED PERIPROSTHETIC FRACTURE OF PROXIMAL FEMUR. (B)(6) 2020 IMPLANT LABELS: 9 DALL-MILES CABLE AND SLEEVE SETS, SMALL DALL-MILES TROCHANTERIC GRIP, 195/17 RESTORATION MODULAR STEM, 21/@0 V-40 BODY, (B)(4) V-40 LFIT HEAD, 40/26 UHR BIPOLAR. NO CLINICAL OR PMH,NO DATED SERIAL X-RAYS, NO OPERATIVE REPORTS, NO EXAMINATION OF EXPLANTED COMPONENTS. WHILE THE SUBMITTED X-RAY APPEARS TO CONFIRM THE EVENT DESCRIPTION, INSUFFICIENT DATA IS PRESENTED TO CREATE A MEDICAL REPORT FOR THIS CASE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT ON THE (B)(6) 2020 A "REVISION [WAS] PERFORMED AT (B)(6) TODAY WITH DOCTOR. (B)(6) . PRESENTED WITH A PERIPROSTHETIC FRACTURE OF A ¿25+ YEAR OLD HEMIARTHROPLASTY¿ NO OTHER INFO CONCERNING ORIGINAL/PRIMARY SURGERY IS KNOWN."

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT ON THE (B)(6) 2020 A "REVISION [WAS] PERFORMED AT (B)(6) MEMORIAL TODAY WITH DOCTOR. PT. PRESENTED WITH A PERIPROSTHETIC FRACTURE OF A ¿25+ YEAR OLD HEMIARTHROPLASTY¿ NO OTHER INFO CONCERNING ORIGINAL/PRIMARY SURGERY IS KNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503228 OMNIFLEX M-HA HIP STEM PROSTHESIS, HIP, HEMI-, FEMORAL, METAL KWL STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R