BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FEMORAL COMPONENT

    MDR report key: 21890590 · Received April 23, 2025

    Report

    Report Number
    0001822565-2025-01122
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    April 14, 2025
    Report Date
    May 22, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). G2: FOREIGN COUNTRY: SPAIN. G2: JOURNAL ARTICLE: SÁNCHEZ DEL SAZ, J., CODERCH CARRETERO, J., GARCÍA COIRADAS, J., & GARCÍA CRESPO, R. (2025). WATCH OUT YOUR PINS! PERIPROSTHETIC FEMORAL FRACTURE AT TRACKING PIN SITE EARLY AFTER ROBOTIC-ASSISTED KNEE ARTHROPLASTY TREATED WITH DUAL NAIL-PLATE FIXATION. TRAUMA CASE REPORTS, 57, 101182. HTTPS://DOI.ORG/10.1016/J.TCR.2025.101182. H6: MECHANICAL (G04) - FEMUR. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. THE EVENT IS CONFIRMED BY REVIEW OF MEDICAL RECORDS. 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. OPERATIVE NOTES AND CLINICAL RECORDS PROVIDED AND REVIEWED BY A HEALTHCARE PROFESSIONAL STATE THAT TWO MONTHS POSTOPERATIVELY, A PATIENT SUSTAINED A GROUND-LEVEL FALL AND PRESENTED WITH SEVERE PAIN, SWELLING, AND DEFORMITY. RADIOGRAPHIC IMAGING CONFIRMED A DISPLACED METAPHYSO-DIAPHYSEAL FEMORAL PERIPROSTHETIC FRACTURE THROUGH THE PREVIOUS FEMORAL PIN HOLES, WITHOUT SIGNS OF IMPLANT LOOSENING. THE PATIENT UNDERWENT CLOSED REDUCTION AND OSTEOSYNTHESIS WITH NAILING USING A LONG CEPHALOMEDULLARY ANTEROGRADE FEMORAL NAIL AND LATERAL FEMORAL PLATING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A JOURNAL ARTICLE THAT THE PATIENT HAD A GROUND LEVEL FALL APPROXIMATELY 2 MONTHS POST-OP AND SUFFERED A PERIPROSTHETIC FRACTURE THROUGH THE PIN SITES. SUBSEQUENTLY, THE PATIENT UNDERWENT A CLOSED REDUCTION AD OSTEOSYNTHESIS WITH NAILING. ATTEMPTS HAVE BEEN MADE AND ALL AVAILABLE INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515509 UNKNOWN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H