BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALACOS CEMENT

    MDR report key: 16715705 · Received April 11, 2023

    Report

    Report Number
    0001822565-2023-00986
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    June 30, 2022
    Report Date
    May 19, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    N/A
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: ONE YEAR POST-OP, PATIENT EXPERIENCED PAIN, AND SWELLING. X-RAY FOUND ASEPTIC LOOSENING AT THE TIP OF THE STEM. REVISION WAS PERFORMED, HOWEVER, OPS NOTES WERE NOT PROVIDED. 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

    (B)(4). 150375 - OSS CEMENTED IM STEM 15X225 - 093670. 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. 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.

    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
    1623678 UNKNOWN PALACOS CEMENT BONE CEMENT LOD ZIMMER BIOMET, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H SEE H10 NARRATIVE.