BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STAR ANKLE

    MDR report key: 12478319 · Received September 15, 2021

    Report

    Report Number
    0008031020-2021-00414
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    June 23, 2021
    Report Date
    December 29, 2021
    Manufacturer
    STRYKER GMBH
    Product Code
    NTG
    PMA / PMN Number
    P050050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE CORRECTION TO B1 AND H6 DEVICE AND CLINICAL SIGNS CODES. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WAS PROVIDED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT SUCH AS X-RAYS AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

    Description of Event or Problem · 0

    A PATIENT REPORTED VIA MEDWATCH MW5102775 THE FOLLOWING COMPLAINT: "PREAMBLE I'M A MAN IN GOOD HEALTH. ABOUT 20 POUNDS HEAVY FROM MY BEST WEIGHT. I'M 5'11" LBS. ABOUT 15 YEARS AGO I SLIPPED ON ICE AND BROKE OFF ABOUT A THUMB SIZE PIECE OF THE BOTTOM OF MY FIBULA IN MY RIGHT LEG. AT THAT TIME IT WAS PUT BACK IN PLACE AND RIGID PERFORATED METAL STRIP WITH 6 SCREWS WAS PUT IN TO HOLD IT TOGETHER AND IN PLACE. OVER THE YEARS MY ANKLE AND FOOT STARTED HURTING. IN 2017 I HAD BONE FUSION SURGERY FOR ARTHRITIS AND A LOW ARCH. I THINK IT INVOLVED PLATES AND CREWS FOR MY NAVICULAR, MY CUNEIFORM AND MY BIG TOE FIRST METATARSAL. AT THAT TIME I ALSO HAD MY TWO PERONEAL TENDONS SEWN TOGETHER BECAUSE ONE OF THEM WAS NEARLY TORN THROUGH. ALSO, SHE REMOVED THE METAL STRIP AND SCREWS FROM MY TIBIA. IN 2020 SHE DID MY FOOT ARTHRITIS SURGERY DONE AGAIN, BECAUSE IT WAS HURTING MORE AND MORE AND SHE SAID THE FUSION DIDN'T QUITE TAKE TOGETHER LIKE IT SHOULD HAVE, SHE TOOK BONE FROM MY HIP AND NOW THAT PART OF MY FOOT FEELS GREAT. I HAD ALL OF THIS DONE AT (B)(6). THEN SHE (FOOT SURGEON) TOLD ME THE ARTHRITIS PAIN IN AND AT MY ANKLE CALLED FOR A PROSTHETIC ANKLE AND SHE DIDN'T DO THAT TYPE OF WORK. SHE REFERRED ME TO HOSPITAL ON. PROBLEM I GOT A STAR PROSTHETICS REPLACEMENT ANKLE THERE ON 2020 AND IT WENT WELL WITH NO PROBLEM WITH MY ANKLE, MY FOOT STILL HURT HELL JUST IN FRONT OF MY ANKLE. I GOT A TALONAVICULAR FUSION ON THAT SAME FOOT ON 2021 DUE TO ARTHRITIS AND GRINDING IN THAT JOINT. BOTH WERE BY THE SAME SURGEON. I FOLLOWED DOCTORS DOCTOR'S ORDERS AND DIDN'T USE MY FOOT AFTER THAT. ON [DATE REDACTED] I HAD A POST OP APPOINTMENT FOR MY FUSION SURGERY. AT THAT APPOINTMENT THE SURGEON TOLD ME TO START PUTTING UP TO ABOUT 30% WEIGHT ON MY HEEL SOMETIMES TO GET FEEL FOR IT, BUT NOT OVERLOAD IT. HE ALSO TOLD ME TO START JUST WORKING MY ANKLE JOINT WHILE I WAS SITTING BY JUST POINTING THE FRONT OF MY FEET DOWN AND UP OVER AND OVER. THAT'S WHEN THE TROUBLES STARTED. MY ANKLE IS STARTING TO HURT AND IT FEELS JUST A LITTLE LOOSE AND UNSTABLE, AND IT LITERALLY SQUEAKS LIKE A ROCKING CHAIR ON OLD WOOD FLOOR. THIS IS NO EXAGGERATION. IF YOU WANT TO CALL ME I'LL SQUEAK IT FOR YOU AND YOU CAN HEAR IT OVER THE PHONE. I DON'T CARE THAT MUCH ABOUT HOW MY ANKLE AND FOOT SOUND OR LOOK. IT CONCERNS ME THAT IT IS GETTING WORSE AND IT FEELS SLIGHTLY LIKE IT'S JUST NOT AS SOLID IN THE ANKLE AS IT WAS BEFORE THE FOOT BONE FUSION. THIS MAY BE LESS OF A PROBLEM THAN I'M MAKING IT TO BE. MAYBE THE SURGEON IS STILL GOIN TO FIX IT. HE HASN'T "THROWN ME TO THE WOLVES" AND WE ARE HAVING MORE FOLLOW UP APPOINTMENTS. THANK YOU. I'M NOT COMPLAINING ABOUT MY SURGEON, I'M REPORTING A PROBLEM WITH MY 7 MONTHS OLD STAR ANKLE REPLACEMENT ANKLE."

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    A PATIENT REPORTED VIA MEDWATCH MW5102775 THE FOLLOWING COMPLAINT: "PREAMBLE I'M A MAN IN GOOD HEALTH. ABOUT 20 POUNDS HEAVY FROM MY BEST WEIGHT. I'M 5'11" LBS. ABOUT 15 YEARS AGO I SLIPPED ON ICE AND BROKE OFF ABOUT A THUMB SIZE PIECE OF THE BOTTOM OF MY FIBULA IN MY RIGHT LEG. AT THAT TIME IT WAS PUT BACK IN PLACE AND RIGID PERFORATED METAL STRIP WITH 6 SCREWS WAS PUT IN TO HOLD IT TOGETHER AND IN PLACE. OVER THE YEARS MY ANKLE AND FOOT STARTED HURTING. IN 2017 I HAD BONE FUSION SURGERY FOR ARTHRITIS AND A LOW ARCH. I THINK IT INVOLVED PLATES AND CREWS FOR MY NAVICULAR, MY CUNEIFORM AND MY BIG TOE FIRST METATARSAL. AT THAT TIME I ALSO HAD MY TWO PERONEAL TENDONS SEWN TOGETHER BECAUSE ONE OF THEM WAS NEARLY TORN THROUGH. ALSO, SHE REMOVED THE METAL STRIP AND SCREWS FROM MY TIBIA. IN 2020 SHE DID MY FOOT ARTHRITIS SURGERY DONE AGAIN, BECAUSE IT WAS HURTING MORE AND MORE AND SHE SAID THE FUSION DIDN'T QUITE TAKE TOGETHER LIKE IT SHOULD HAVE, SHE TOOK BONE FROM MY HIP AND NOW THAT PART OF MY FOOT FEELS GREAT. I HAD ALL OF THIS DONE AT VA MEDICAL CENTER. THEN SHE (FOOT SURGEON) TOLD ME THE ARTHRITIS PAIN IN AND AT MY ANKLE CALLED FOR A PROSTHETIC ANKLE AND SHE DIDN'T DO THAT TYPE OF WORK. SHE REFERRED ME TO HOSPITAL ON. PROBLEM I GOT A STAR PROSTHETICS REPLACEMENT ANKLE THERE ON 2020 AND IT WENT WELL WITH NO PROBLEM WITH MY ANKLE, MY FOOT STILL HURT HELL JUST IN FRONT OF MY ANKLE. I GOT A TALONAVICULAR FUSION ON THAT SAME FOOT ON 2021 DUE TO ARTHRITIS AND GRINDING IN THAT JOINT. BOTH WERE BY THE SAME SURGEON. I FOLLOWED DOCTORS DOCTOR'S ORDERS AND DIDN'T USE MY FOOT AFTER THAT. ON [DATE REDACTED] I HAD A POST OP APPOINTMENT FOR MY FUSION SURGERY. AT THAT APPOINTMENT THE SURGEON TOLD ME TO START PUTTING UP TO ABOUT 30% WEIGHT ON MY HEEL SOMETIMES TO GET FEEL FOR IT, BUT NOT OVERLOAD IT. HE ALSO TOLD ME TO START JUST WORKING MY ANKLE JOINT WHILE I WAS SITTING BY JUST POINTING THE FRONT OF MY FEET DOWN AND UP OVER AND OVER. THAT'S WHEN THE TROUBLES STARTED. MY ANKLE IS STARTING TO HURT AND IT FEELS JUST A LITTLE LOOSE AND UNSTABLE, AND IT LITERALLY SQUEAKS LIKE A ROCKING CHAIR ON OLD WOOD FLOOR. THIS IS NO EXAGGERATION. IF YOU WANT TO CALL ME I'LL SQUEAK IT FOR YOU AND YOU CAN HEAR IT OVER THE PHONE. I DON'T CARE THAT MUCH ABOUT HOW MY ANKLE AND FOOT SOUND OR LOOK. IT CONCERNS ME THAT IT IS GETTING WORSE AND IT FEELS SLIGHTLY LIKE IT'S JUST NOT AS SOLID IN THE ANKLE AS IT WAS BEFORE THE FOOT BONE FUSION. THIS MAY BE LESS OF A PROBLEM THAN I'M MAKING IT TO BE. MAYBE THE SURGEON IS STILL GOING TO FIX IT. HE HASN'T "THROWN ME TO THE WOLVES" AND WE ARE HAVING MORE FOLLOW UP APPOINTMENTS. THANK YOU. I'M NOT COMPLAINING ABOUT MY SURGEON, I'M REPORTING A PROBLEM WITH MY 7 MONTHS OLD STAR ANKLE REPLACEMENT ANKLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375135 UNKNOWN STAR ANKLE PROSTHESIS, ANKLE, UNCEMENTED, NON-CONSTRAINED NTG STRYKER GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other