BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSS TO CPS EXP INTERCA SEG 6CM

    MDR report key: 16194014 · Received January 18, 2023

    Report

    Report Number
    0001825034-2023-00078
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 21, 2022
    Report Date
    April 4, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KRO
    UDI-DI
    00887868346750
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. H6: PROPOSED COMPONENT CODE: MECHANICAL (G04) - FEMUR. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO 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

    MEDICAL PRODUCT: OSS DSTL FMRL REPLACMENT 6CM: CATALOG#CP0001910, LOT#804820. CPS SHORT ANCHOR PLUG 10MM: CATALOG#178552, LOT#331670. CPS TRANSVERSE PIN 6PK 32MM: CATALOG#178527, LOT#179940. CPS TRANSVERSE PIN 6PK 24MM: CATALOG#178525, LOT#262910. CPS XS SHT SPDL W PINS 400LBF: CATALOG#178362, LOT#171130. CPS NUT CO-CR-MO ALLOY: CATALOG#178512, LOT#099440. CPS CENTERING SLEEVE 13MM: CATALOG#178535, LOT#353520. OSS POLY LOCK PIN: CATALOG#150478, LOT#668640. OSS RS POLY TIBIAL BEARING 14: CATALOG#161029, LOT#409350. OSS RS NON MOD PLATE LONG 67: CATALOG#161039, LOT#170180. OSS RS AXLE: CATALOG#161035, LOT#220030. OSS RS POLY FEM BUSHINGS SET/2: CATALOG#161034, LOT#456620. OSS REINFORCED YOKE: CATALOG#150493, LOT#110280. OSS POLY TIBIAL BUSHING: CATALOG#150476, LOT#563330. PALACOS R (2X20): CATALOG#66017775, LOT#89945279. REPORT SOURCE: FOREIGN: BELGIUM. THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR EVALUATION AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A ROUTINE FEMORAL EXPANSION PROCEDURE, THE CUSTOM EXPANSION IMPLANT FAILED TO EXTEND TO THE INTENDED LENGTH. AFTER A SURGICAL DELAY OF TWO (2) HOURS ATTEMPTING TO EXPAND THE DEVICE, IT WAS DETERMINED THAT THE EXPANSION WAS NOT POSSIBLE AND THE PROCEDURE WAS UNABLE TO BE COMPLETED. THE PRODUCT REMAINS IMPLANTED AND THE FINAL OUTCOME OF THE PATIENT IS UNKNOWN AT THE TIME OF THIS REPORT. DUE DILIGENCE IS IN PROCESS FOR THIS COMPLAINT; TO DATE NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923582 OSS TO CPS EXP INTERCA SEG 6CM PROSTHESIS, KNEE KRO ZIMMER BIOMET, INC. N/A 805190 00887868346750

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Hospitalization| R SEE H10 NARRATIVE.