BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALACOS RG 1X40 SINGLE

    MDR report key: 18874040 · Received March 11, 2024

    Report

    Report Number
    0001822565-2024-00783
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 5, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LOD
    PMA / PMN Number
    K031673
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 00111314001, ITEM NAME: PALACOS RG 1X40 SINGLE, LOT / SOFTWARE RELEASE # 87794709. 00111314001, ITEM NAME: PALACOS RG 1X40 SINGLE, LOT # 87424699. 151805, ITEM NAME: OSS 3CM RESURFACING RT, 462860. 150370, ITEM NAME: OSS CEMENTED IM STEM 16X150, LOT # 067110. 150477, ITEM NAME: OSS POLY FEMORAL BUSHINGS, LOT # 378090. 150476, ITEM NAME: OSS POLY TIBIAL BUSHING, LOT # 438170. 150493, ITEM NAME: OSS REINFORCED YOKE, LOT # 113520. 150422, ITEM NAME: OSS MOD TIB BASEPLATE 71MM, LOT # 993770. 150427, ITEM NAME: OSS TIB BLK AUG 10X71/75 UNIV, LOT # 683320. 150412, ITEM NAME: OSS TIBIAL POLY BEARING 16MM, LOT # 380610. 150480, ITEM NAME: OSS AXLE, LOT # 336910. 150361, ITEM NAME: OSS CEMENTED IM STEM 12MMX90MM, LOT # 092530. 150478, ITEM NAME: OSS POLY LOCK PIN, LOT # 210660. . MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS 0001822565-2024-00782 AND 0001822565-2024-00784. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED H3 OTHER TEXT : DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, G3, G6, H2, H6, H11. BASED ON THE INFORMATION PROVIDED, THE PATIENT HAD A HISTORY OF MULTIPLE JOINT SURGERIES, INCLUDING TOTAL AND PARTIAL KNEE AND HIP REPLACEMENTS. ADDITIONALLY, THE PATIENT'S OBESE STATUS INCREASED MECHANICAL LOAD ON THE JOINT IMPLANTS. REPEATED SURGERIES INCREASE THE RISK OF BONE QUALITY DEGRADATION WHICH COULD AFFECT THE STABILITY AND LONGEVITY OF THE IMPLANT FIXATION. THE CAUSE OF THE LOOSENING OF THE FEMORAL COMPONENT IS LIKELY MULTIFACTORIAL, WITH CONTRIBUTING FACTORS SUCH AS PATIENT-RELATED INFLUENCES (E.G., WEIGHT), PREVIOUS SURGICAL INTERVENTIONS, AND THE COMPLEX NATURE OF REVISION ARTHROPLASTY. THERE IS NO EVIDENCE TO SUGGEST THAT PALACOS® R+G OR PALACOS® R DIRECTLY CAUSED OR CONTRIBUTED TO THE LOOSENING OF THE FEMORAL IMPLANT. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: HINGED PROSTHESIS RIGHT TOTAL KNEE ARTHROPLASTY WITH SIGNIFICANT LOOSENING OF THE FEMORAL COMPONENT, OSTEOPENIA IS PRESENT. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE COMPLAINT IS NOT CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 5 YEARS AND 9 MONTHS POST IMPLANTATION DUE TO FEMORAL LOOSENING. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076895 PALACOS RG 1X40 SINGLE PROSTHETIC, HIP LOD ZIMMER BIOMET, INC. N/A 89344763

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention| H PLEASE SEE H10