BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE SCR 6.5X20 SELF-TAP

    MDR report key: 8087816 · Received November 19, 2018

    Report

    Report Number
    0002648920-2018-00821
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    April 7, 2018
    Report Date
    December 11, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    K934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS IDENTIFIED AN INTERNAL SOFTWARE ERROR PRODUCED AND SUBMITTED AN INVALID D2 DEVICE PRODUCT CODE IN THE PREVIOUS SUBMISSIONS RELATED TO THIS REPORTING. THE DEVICE PRODUCT CODE HAS BEEN UPDATED WITH NO FURTHER CHANGES. 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.

    Description of Event or Problem · 0

    NO FURTHER INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 00625006530, BONE SCR 6.5X30 SELF-TAP, LOT# 63592262. ITEM# UNKNOWN, UNKNOWN SCREW, LOT# UNKNOWN. ITEM# 650-1055, CER BIOLOXD OPTION HD 28MM, LOT# 236390. ITEM# 110024463, G7 DUAL MOBILITY LINER 42MM E, LOT# 592890. ITEM# 51-107140, TPRLC 133 MP TYPE1 PPS HO 14.0, LOT# 3925972. ITEM# EP-200148, ACT ARTIC E1 HIP BRG 28X42MM, LOT# 213650. ITEM# 650-1065, CER OPTION TYPE 1 TPR SLEVE -3, LOT# UNKNOWN. ITEM# 010000663, G7 PPS LTD ACET SHELL 52E, LOT# 3921114. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. REPORTED EVENT WAS CONFIRMED BY REVIEW OF OPERATIVE NOTES WHICH INDICATED DURING PROCEDURE BRISK BLEEDING FROM THE CANCELLOUS BONE AT THE MARGIN OF THE CUP AND FROM THE INFERIOR PORTION OF THE OBTURATOR WAS NOTED. DUE TO PATIENT EXPERIENCING A SIGNIFICANT DROP IN BLOOD PRESSURE RESULTING IN PATIENT INSTABILITY, MULTIPLE UNITS OF PACKED RED BLOOD CELLS, FFP, AND EPINEPHRINE WAS REQUIRED. BONE WAX WAS USED TO SEAL THE CANCELLOUS BONE AROUND THE CUP AND ALSO AROUND THE FEMUR. THE WOUND WAS IRRIGATED AND BLEEDING HAD REDUCED. ANOTHER DOSE OF ARISTA POWDER, THROMBIN GELFOAM, A GRAM OF VANCOMYCIN POWDER WAS PLACED INTO THE WOUND AND THE CAPSULE WAS CLOSED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2018 - 04600, 0002648920 - 2018 - 00652.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN INITIAL TOTAL HIP ARTHROPLASTY, THE PATIENT EXPERIENCED INCREASED BLOOD LOSS OF 1-2 LITERS. WHILE REAMING THE ACETABULUM, A CENTRAL DEFECT WAS CREATED WITH THE REAMER. DURING CLOSURE, IT WAS NOTICED THERE WAS TOO MUCH BLOOD WELLING UP. SUTURES WERE REMOVED AND THE HIP WAS DISLOCATED. BLEEDING WAS COMING FROM THE CANCELLOUS BONE AT THE MARGINS OF THE CUP AND FROM THE INFERIOR PORTION OF THE OBTURATOR. IT WAS ATTEMPTED TO PACK THESE WITH THROMBIN AND GELFOAM, BUT IT WAS UNSUCCESSFUL. THE PATIENT¿S PRESSURES DROPPED AND BECAME UNSTABLE, REQUIRING MULTIPLE UNITS OF PACKED RED BLOOD CELLS, FFP, AND EPINEPHRINE. BONE WAX WAS USED TO SEAL THE CANCELLOUS BONE AROUND THE CUP AND FEMUR. THE BLEEDING HAD IMPROVED. ANOTHER DOSE OF ARISTA POWDER, THROMBIN GELFOAM, AND A GRAM OF VANCOMYCIN POWDER WERE PLACED. THE CAPSULE WAS THEN CLOSED. THE PATIENT WAS TRANSFERRED TO INTERVENTIONAL RADIOLOGY WHERE AN ANGIOGRAM FOUND NO VESSEL INJURY. IT WAS NOTED THAT ONE OF THE ACETABULAR SCREWS THAT HAD BEEN CUT TO SIZE DURING THE PROCEDURE, STILL APPEARED TO BE TOO LONG; HOWEVER, THERE WAS NO VESSEL DAMAGE OR BLEEDING AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924082 BONE SCR 6.5X20 SELF-TAP PROSTHESIS HIP MRA ZIMMER MANUFACTURING B.V. N/A 63585012

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R