BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORATION ADM X3 INS 28/48

    MDR report key: 14029822 · Received April 6, 2022

    Report

    Report Number
    0002249697-2022-00480
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    July 4, 2022
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    UDI-DI
    04546540638977
    PMA / PMN Number
    K093644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: MODULAR DUAL MOBILITY INSERT; CAT#626-00-42E ; LOT#73068904. PRIMARY SECUR-FIT PLUS MAX #8/14; CAT#6054-0814S ; LOT#HA6AXA. DELTA C-TAPER HEAD 28MM +5; CAT#18-2805 ; LOT#72455401. TRIDENTII TRITANIUM SOLID 52E; CAT#700-04-52E; LOT#71575501A. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING PAIN INVOLVING A ADM LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: DEVICE EVALUATION AND RESULTS: MATERIAL ANALYSIS, FUNCTIONAL AND DIMENSIONAL INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. VISUAL INSPECTION - THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS SHOW A RECENTLY EXPLANTED DEVICE WITH BLOOD ON ITS SURFACES. NOTHING ELSE NOTED. CLINICAL REVIEW: A REVIEW OF THE PROVIDED MEDICAL RECORDS BY A CLINICAL CONSULTANT STATED THE FOLLOWING COMMENT: I CAN CONFIRM THAT AN IMPLANT WAS REMOVED SINCE I WAS ABLE TO SEE PHOTOGRAPHS OF THE EXPLANTED DEVICES. REGARDING THE POSSIBLE ROOT CAUSE OF THIS EVENT, I CANNOT DETERMINE IT WITH CERTAINTY. WHILE A BONE SCAN REPORT QUESTIONS POSSIBLE LOOSENING, I HAVE NO OFFICE NOTES OR OPERATION NOTE OR RADIOGRAPHS TO CORROBORATE THE REASON FOR REMOVAL. PRODUCT HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSION: AN EVENT REGARDING PAIN INVOLVING A ADM LINER WAS REPORTED.THE EVENT WAS NOT CONFIRMED . THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS OFFICE NOTES, OPERATION NOTE, RADIOGRAPHS ARE NEEDED. IF ADDITIONAL INFORMATION ARE RECEIVED, THIS INVESTIGATION WILL BE REOPENED AND RE-EVALUATED.

    Description of Event or Problem · 0

    PT EXPERIENCING PAIN IN RIGHT HIP. REVISION TOTAL HIP.

    Description of Event or Problem · 0

    PT EXPERIENCING PAIN IN RIGHT HIP. REVISION TOTAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812888 RESTORATION ADM X3 INS 28/48 PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU MEH STRYKER ORTHOPAEDICS-MAHWAH 1236-2-848 73528901 04546540638977

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Hospitalization| R