BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CER BIOLOXD OPTION HD 28MM

    MDR report key: 7828431 · Received August 29, 2018

    Report

    Report Number
    0001825034-2018-08440
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    April 4, 2017
    Report Date
    October 8, 2018
    Manufacturer
    .
    Product Code
    LZO
    PMA / PMN Number
    PK082996
    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

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 650-1065 CER OPTION TYPE 1 TPR SLEVE-3 LOT# 2887154. COMPLAINT WAS CONFIRMED THROUGH SURGICAL NOTES WHICH INDICATED WELLING UP OF BLOOD WITHIN IN THE CUP WAS NOTED DURING THE CLOSURE OF THE WOUND. UPON INSPECTION, IT WAS IDENTIFIED THAT THE HIP WAS DISLOCATED. BRISK BLEEDING FROM THE CANCELLOUS BONE AT THE MARGIN OF THE CUP AND FROM THE INFERIOR PORTION OF THE OBTURATOR WAS NOTED. PATIENT'S PRESSURES BEGAN TO DROP AND PATIENT BECAME UNSTABLE, REQUIRING MULTIPLE UNITS OF PACKED RED BLOOD CELLS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM# 010000663, G7 PPS LTD ACET SHELL 52E, LOT# 3921114; 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# 00625006530, BONE SCR 6.5X30 SELF-TAP, LOT# 63592262; ITEM# 00625006520, BONE SCR 6.5X20 SELF-TAP, LOT# 63585012; ITEM# UNKNOWN, UNKNOWN SCREW, LOT# UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 08448; 0001825034 - 2018 - 08443; 0001825034 - 2018 - 08442; 0001825034 - 2018 - 08441; 0001825034 - 2018 - 08431.

    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
    667436 CER BIOLOXD OPTION HD 28MM PROSTHESIS HIP LZO . N/A 236390

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R