BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER PROSTHESIS SCREW

    MDR report key: 7248103 · Received February 7, 2018

    Report

    Report Number
    0001825034-2018-00720
    Event Type
    Injury
    Date Received
    February 7, 2018
    Date of Event
    March 18, 2014
    Report Date
    February 5, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSD
    PMA / PMN Number
    PN/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATION AND ANOMALIES. THIS DEVICE IS USED FOR TREATMENT. COMPATIBILITY CHECK FOR ALL THE PARTS CARRIED OUT AND THE PARTS WERE FOUND TO BE COMPATIBLE. PART AND LOT INFORMATION UNAVAILABLE FOR THE FOURTH SCREW. FOLLOW UP ATTEMPT COMPLETED AND NO INFORMATION OBTAINED. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. REVIEW OF THE OPERATIVE RECORDS INDICATES THAT THE SURGEON NOTED NO COMPLICATIONS DURING SURGERY. WITHOUT THE OPPORTUNITY TO EXAMINE THE COMPLAINT PRODUCT, ROOT CAUSE CANNOT BE DETERMINED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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. RELATED MEDWATCHES/ CONCOMITANT PRODUCT: 0001825034-2018-00710 ¿ CAT#113630 ¿ LOT#688080 - COMP PRIMARY STEM 10 MM MINI, 0001825034-2018-00711 ¿ CAT#115340 ¿ LOT#024850 - COMP RVS HMRL TI TRAY 44 MM, 0001825034-2018-00712 ¿ CAT#XL-115363 ¿ LOT#333000 - ARCOM XL 44-36 STD HMRL BRNG, 0001825034-2018-00713 ¿ CAT#115310 ¿ LOT#764970 - COMP RVRS SHLDR GLNSP STD 36 MM, 0001825034-2018-00714 ¿ CAT#010000589 ¿ LOT#041180 - COMP RVRS 25 MM BSPLT HA+ADPTR, 0001825034-2018-00715 ¿ CAT#115383 ¿ LOT#894170 - COMP RVS CNTRL SCR 6.5 X 35 MM ST, 0001825034-2018-00716 ¿ CAT#180500 ¿ LOT#746090 - COMP LOCKING SCREW 4.75 X 15 MM, 0001825034-2018-00718 ¿ CAT#180502 ¿ LOT#324660 - COMP LOCKING SCREW 4.75 X 25 MM, 0001825034-2018-00719 ¿ CAT#180509 ¿ LOT#388440 - COMP NON-LCKNG SCREW 4.75 X 25 MM.

    Description of Event or Problem · 1

    CLINICAL STUDY (B)(6) - PATIENT UNDERWENT TOTAL SHOULDER REPLACEMENT ON (B)(6) 2014. PAIN AFFECTING ACTIVITIES OF DAILY LIVING WAS REPORTED 6 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93029 UNKNOWN SHOULDER PROSTHESIS SCREW PROSTHESIS - SHOULDER HSD ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other