BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE LINR-NEUT-40X58/60 RESTORIS XLVE

    MDR report key: 5248584 · Received November 24, 2015

    Report

    Report Number
    3005985723-2015-00279
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    MAKO SURGICAL CORP.
    Product Code
    OQG
    PMA / PMN Number
    K122158
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING INFECTION INVOLVING A MAKO LINER WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD AND RESULTS: DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED, HOWEVER AN IMAGE WAS PROVIDED. BIOLOGICAL DEBRIS WAS NOTED ON THE LINER. OTHERWISE THE LINER WAS INTACT AND UNREMARKABLE. MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF THE PROVIDED INFORMATION BY A CLINICAL CONSULTANT INDICATED THAT: NO REVISION OPERATIVE REPORT, NO BACTERIAL DATA, ARE NO EXAMINATION OF THE EXPLANTED COMPONENTS ARE AVAILABLE FOR REVIEW. THERE IS NO EVIDENCE THIS EARLY POST-OPERATIVE PERIPROSTHETIC INFECTION WAS RELATED TO FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING OR MATERIALS. DEVICE HISTORY REVIEW: ALL DEVICES IN THE REPORTED LOT WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT AND STERILE LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. FURTHER INFORMATION SUCH AS RETURN OF DEVICE, PATHOLOGY REPORT, OPERATIVE REPORTS, ADDITIONAL X-RAYS, PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO INVESTIGATE THIS EVENT FURTHER. IF ADDITIONAL INFORMATION AND/OR DEVICE BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT. NO.: 6519-1-040, DELTA UN.FEM HD 40MM R40 16/18, LOT CODE: 52416304. CAT. NO.: 6519-T-100, UNI ADAPTOR SLEEVE V40 TI, LOT CODE: 52302402. CAT. NO.: 0580-1-441, EXETER V40 STEM 44MM NO 1, LOT CODE: G5695781. CAT. NO.: 186005-25, ACE BONE SCREW-6.5 DIA-25MM IMPLANT, LOT CODE: 170086-01. CAT. NO.: 186002-58, ACE SHELL-CLUST HOLE POR-58MM IMPLANT, LOT CODE: 030590-01. CAT. NO.: 186005-30, ACE BONE SCREW-6.5 DIA-30MM IMPLANT, LOT CODE: 170108-01. CAT. NO.: 186005-20, ACE BONE SCREW-6.5 DIA-20MM IMPLANT, LOT CODE: 170117-01. AT THIS TIME, IT CANNOT BE DETERMINED IF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S INFECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    WAS NOTIFIED EARLY MORNING ON TUESDAY, (B)(6) 2015, BY THE HOSPITAL THAT DR. (B)(6) HAD AN ADD-ON HIP GOING THAT NIGHT. THE PATIENT WAS REPORTEDLY INFECTED. RIGHT HIP.

    Description of Event or Problem · 1

    WAS NOTIFIED EARLY MORNING ON TUESDAY, (B)(6) 2015, BY THE HOSPITAL THAT DR. (B)(6) HAD AN ADD-ON HIP GOING THAT NIGHT. THE PATIENT WAS REPORTEDLY INFECTED. RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776279 ACE LINR-NEUT-40X58/60 RESTORIS XLVE HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U OQG MAKO SURGICAL CORP. 190341-01

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention