BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCOS CON SZ B STD 70MM

    MDR report key: 11997741 · Received June 15, 2021

    Report

    Report Number
    0001825034-2021-01775
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    June 3, 2021
    Report Date
    October 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    PMA / PMN Number
    K090757
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4 (PART NUMBER). 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

    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. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED DEVIATIONS OR ANOMALIES DURING MANUFACTURING, THE DEVIATIONS OR ANOMALIES WOULD NOT HAVE ATTRIBUTED TO THE EVENT A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, HOWEVER IT WAS NOTED BY THE REPORTER THAT THE DISLOCATION COULD BE THE RESULT OF MALPOSITION OF THE CONE AND/OR PATIENT NONCOMPLIANCE. 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

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION TO CORRECT ANTEVERSION OF THE CONE BODY OF THE STEM. IT WAS NOTED THAT THE PATIENT DISLOCATED BUT NO INJURY WAS SUSTAINED. THE REPORTER ALSO NOTED THAT THE PATIENT WAS VERY DIFFICULT AND WOULD NOT FOLLOW POST OP PROTOCOL. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 00631005836 ¿ LINER ¿ UNKNOWN LOT; 11-262661 ¿ COCR HEAD ¿ 814600; UNKNOWN ARCOS STEM ¿ UNKNOWN PART AND LOT; UNKNOWN CUP ¿ UNKNOWN PART AND LOT. REPORT SOURCE (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR THE INVESTIGATION AS IT IS UNAVAILABLE BY HOSPITAL POLICY. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A HIP REVISION AFTER AN UNKNOWN AMOUNT OF TIME POST IMPLANTATION TO CORRECT ANTEVERSION OF THE CONE BODY OF THE STEM. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901820 ARCOS CON SZ B STD 70MM PROSTHESIS, HIP KWA ZIMMER BIOMET, INC. N/A 036340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10