BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS CEMENTED IM STEM 15X225

    MDR report key: 16582770 · Received March 21, 2023

    Report

    Report Number
    0001825034-2023-00592
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    June 30, 2022
    Report Date
    August 14, 2023
    Manufacturer
    .
    Product Code
    JDI
    UDI-DI
    00880304239036
    PMA / PMN Number
    K123501
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 150422 - OSS MOD TIB BASEPLATE - 489220. 150466 - OSS 7CM DIAHPYSEAL SEGMENT - 809070. 161010 - OSS RS 7 CM ELLIP SEG FMRL-LT - 584970. 161010 - OSS REINFORCED YOKE - 570110. 150476 - OSS POLY TIBIAL BUSHING - 752840. 150478 - OSS POLY LOCK PIN - 630600. 161035 - OSS RS AXLE - 994070. 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 494980. 150415 - OSS TIBIAL POLY BEARING - 022530. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT (ANNEX G) CODE IS MECHANICAL (G04) - STEM. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS/RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL OPERATIVE NOTES WERE NOT PROVIDED. HOWEVER, OFFICE VISITS AFTER THE SURGERY FOUND NO ISSUES AND THE IMPLANT WAS FUNCTIONING AS EXPECTED. AFTER 1 YEAR, THE PATIENT EXPERIENCED PAIN AND SWELLING WITH NO INSTABILITY. ON OFFICE VISIT APPROXIMATELY 16 MONTHS POST IMPLANTATION, BONE SCAN EXAMINATION FOUND THAT THE FEMUR AND TIBIAL STEM WERE UPTAKE AT THE BOTTOM OF THE STEM. THE SURGEON STATED THAT ¿THIS IS ASEPTIC LOOSENING AT THE TIPS OF THE STEMS, THIS IS ALMOST EXPECTED GIVEN THE FACT THAT I DID NOT USE POROUS STEMS, WHICH WOULD HAVE BEEN QUITE A PROBLEM SHOULD WE HAVE BEEN DEALING WITH A PERSISTENT INFECTION. IT IS ALMOST EXPECTED GIVEN THE FACT THAT HE IS RELATIVELY YOUNG AND STILL HAS A LABOR JOB¿ THE PATIENT CONTINUES TO HAVE EXPERIENCED PAIN AND STARTED USING ASSISTIVE DEVICES FOR AMBULATION. NO SIGN OF INFECTION OR REDNESS, DRAINAGE, EDEMA, BRUISING OR TENDERNESS WERE FOUND. PATIENT WAS REVISED 18 MONTHS POST IMPLANTATION, BUT NO OPERATIVE NOTES WERE PROVIDED FOR THE REVIEW. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 150446 - OSS CMNTD PROX TIB STEM - 809070. 150422 - OSS MOD TIB BASEPLATE - 489220. 161010 - OSS RS 7 CM ELLIP SEG FMRL-LT- 584970. 150493 - OSS REINFORCED YOKE - 570110. 150476 - OSS POLY TIBIAL BUSHING - 752840. 150478 - OSS POLY LOCK PIN - 630600. 161035 - OSS RS AXLE - 994070. 150415 - OSS POLY TIBIAL BUSHING - 022530. 161034 - OSS RS POLY FEM BUSHINGS SET/2 - 494980. UNKNOWN PALACOS CEMENT. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2023-00733.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO LOOSENING OF THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A LEFT KNEE REVISION APPROXIMATELY 1.5 YEARS POST IMPLANTATION DUE TO PAIN, SWELLING, SUBLUXATION OF THE PATELLA, ASEPTIC LOOSENING, AND DIFFICULTY AMBULATING. DURING THE REVISION, HETEROTOPIC OSSIFICATION TO BONE WAS NOTED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8036 OSS CEMENTED IM STEM 15X225 PROSTHESIS, KNEE JDI . N/A 093670 00880304239036

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10 NARRATIVE.| SEE H10 NARRATIVE.