BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMP PRIMARY STEM 10MM MINI

    MDR report key: 7248118 · Received February 7, 2018

    Report

    Report Number
    0001825034-2018-00710
    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
    MBF
    PMA / PMN Number
    PK060692
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER-BIOMET COMPLAINT (B)(4). NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED FOR PART NUMBER: 113630 LOT NUMBER: 688080, IT WAS NOTED THAT THE PRODUCT HAD 12 PARTS THAT DEVIATED FROM STANDARDS DUE TO COSMETIC REASONS (BURNS, BURRS AND SCRATCHES). HOWEVER, IT WAS REWORKED ON AND DID NOT LEAD TO THE REJECTION OF THE BATCH. THIS DEVICE IS USED FOR TREATMENT. COMPATIBILITY CHECK FOR ALL THE PARTS CARRIED OUT AND THE PARTS WERE FOUND TO BE COMPATIBLE. A COMPLAINT HISTORY REVIEW FOR THE SAME ISSUE IDENTIFIED 10 OTHER COMPLAINTS FOR PART NUMBER 113630 AND NO OTHER COMPLAINTS FOR PART AND LOT NUMBER (688080) SEARCH. 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. THIS REPORT IS BEING SUBMITTED LATE AS IT HAS BEEN IDENTIFIED IN REMEDIATION. RELATED MEDWATCHES/CONCOMITANT PRODUCT: 0001825034-2018-00711 ¿ CAT#115340 ¿ LOT#024850 - COMP RVS HMRL TI TRAY 44MM, 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 36MM, 0001825034-2018-00714 ¿ CAT#010000589 ¿ LOT#041180 - COMP RVRS 25MM BSPLT HA+ADPTR, 0001825034-2018-00715 ¿ CAT#115383 ¿ LOT#894170 - COMP RVS CNTRL SCR 6.5X35MM ST, 0001825034-2018-00716 ¿ CAT#180500 ¿ LOT#746090 - COMP LOCKING SCREW 4.75X15MM, 0001825034-2018-00718 ¿ CAT#180502 ¿ LOT#324660 - COMP LOCKING SCREW 4.75X25MM, 0001825034-2018-00719 ¿ CAT#180509 ¿ LOT#388440 - COMP NON-LCKNG SCREW 4.75X25MM, 0008125034-2018-00720 ¿ CAT# NI ¿ LOT#NI - EXT-COMPREHENSIVE-REVERSE-UNK.

    Description of Event or Problem · 1

    CLINICAL STUDY 482 - 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
    93390 COMP PRIMARY STEM 10MM MINI PROSTHESIS - SHOULDER MBF ZIMMER BIOMET, INC. N/A 688080

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other