BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JUGGERSTITCH CURVED IMPLANT

    MDR report key: 22095303 · Received May 28, 2025

    Report

    Report Number
    0001825034-2025-01503
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 12, 2025
    Report Date
    October 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBI
    PMA / PMN Number
    K191459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4): THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G2; G3; G6; H1; H2; H3; H6. NO PRODUCT WAS RETURNED OR PICTURES OF THE PRODUCT PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PROVIDED PHOTOS OF THE STICKER SHEETS FROM THE HOSPITAL CONFIRM THE REPORTED PART AND LOT NUMBERS. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. MEDICAL RECORDS 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 WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). MULTIPLE LOT COMBINATIONS WERE REPORTED AS THE POSSIBLE PRODUCT THAT MALFUNCTIONED: ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 66110968. MANUFACTURE DATE: 6/19/2024. EXPIRATION DATE: 6/19/2028. UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 66110968. MANUFACTURE DATE: 6/19/2024. EXPIRATION DATE: 6/19/2028. UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 67063241. MANUFACTURE DATE: 12/4/2024. EXPIRATION DATE: 12/4/2029. UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 67063241. MANUFACTURE DATE: 12/4/2024. EXPIRATION DATE: 12/4/2029. UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 66111019. MANUFACTURE DATE: 6/14/2024. EXPIRATION DATE: 6/14/2028. UDI: (B)(4). ITEM#: 110024773, JUGGERSTITCH CURVED IMPLANT; LOT#: 66111004. MANUFACTURE DATE: 6/14/2023. EXPIRATION DATE: 6/14/2028. UDI: (B)(4). H3: CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. G2: FOREIGN: SPAIN. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR 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 WHILE IMPLANTING THE JUGGERSTITCH, THE NEEDLE OF THE PRODUCT FRACTURED. THE FRACTURED PIECE WAS REMOVED FROM THE PATIENT WITH NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715247 JUGGERSTITCH CURVED IMPLANT FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE/SPORTS MEDICINE MBI ZIMMER BIOMET, INC. SEE H11 NARRATIVE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male SEE H11 NARRATIVE.