BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V40 COCR LFIT HEAD 36MM/+5

    MDR report key: 10072691 · Received May 19, 2020

    Report

    Report Number
    0002249697-2020-00960
    Event Type
    Injury
    Date Received
    May 19, 2020
    Date of Event
    April 27, 2020
    Report Date
    August 17, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    UDI-DI
    07613327032314
    PMA / PMN Number
    K173499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT: AN EVENT REGARDING DISLOCATION INVOLVING A METAL HEAD WAS REPORTED. CONCLUSION: BASED ON THE INFORMATION PROVIDED THERE IS NO INDICATION OR ALLEGATION THAT THE DEVICE REPORTED IN THIS INVESTIGATION CONTRIBUTED TO THE EVENT AND IS THEREFORE CONSIDERED CONCOMITANT. DURING REVISION SURGERY, IT IS CONSIDERED GOOD SURGICAL PRACTICE TO ALWAYS REPLACE BEARING COMPONENTS SUCH AS THE TIBIAL INSERT OR HIP LINER INCLUDING FEMORAL HEAD WITH NEW DEVICES, ALSO BECAUSE SERVICE LIFE DAMAGE OR WEAR IS NOT ALWAYS READILY VISIBLE AND THESE COMPONENTS ARE USUALLY MODULAR AND REMOVAL IS EASY AND STRAIGHTFORWARD. THE LINER AND SHELL COMPONENTS WERE NON-STRYKER DEVICES. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.

    Description of Event or Problem · 0

    PATIENT WAS BEING REVISED FOR RECURRENT DISLOCATION. IT WAS FOUND THAT THE DE PUY PINNACLE LINER HAD DISLOCATED FORM THE SHELL, ONCE THE PATIENT WAS OPEN. THE SURGEON REVISED THE DE PUY LINER TO A CONSTRAINED LINER AND CHANGED OUR HEAD TO MATCH THE INNER DIAMETER OF THE NEW LINER. HE DID NOT BELIEVE THERE WAS ANY ISSUE WITH OUR HEAD.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THAT DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT WAS BEING REVISED FOR RECURRENT DISLOCATION. IT WAS FOUND THAT THE DEPUY PINNACLE LINER HAD DISLOCATED FORM THE SHELL, ONCE THE PATIENT WAS OPEN. THE SURGEON REVISED THE DE PUY LINER TO A CONSTRAINED LINER AND CHANGED OUR HEAD TO MATCH THE INNER DIAMETER OF THE NEW LINER. HE DID NOT BELIEVE THERE WAS ANY ISSUE WITH OUR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536001 V40 COCR LFIT HEAD 36MM/+5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH 6260-9-236 MNREXR 07613327032314

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention