BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURASUL, ALPHA INSERT, II/32

    MDR report key: 8088309 · Received November 20, 2018

    Report

    Report Number
    0009613350-2018-01156
    Event Type
    Injury
    Date Received
    November 20, 2018
    Date of Event
    October 30, 2018
    Report Date
    May 31, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K013935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR-REVIEW: REF:(B)(4) ; LOT:2941733. YIELD:100. DELIVERED:100. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:(B)(4); LOT:2945715. YIELD:50. DELIVERED:50. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. REF:(B)(4) LOT:2817021. YIELD:39. DELIVERED:39. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION EVENT DESCRIPTION: IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL RIGHT HIP PROCEDURE ON (B)(6) 2018. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO INSTABILITY, SUBLUXING ON (B)(6) 2018. LINER WAS REPLACED WITH AN ALPHA DURASUL HOODED LINER. HEAD (+0) WAS REPLACED WITH A HEAD (+3.5). REVIEW OF RECEIVED DATA: IMAGE 1- AP RIGHT HIP WITH EXTENSIVE ARTIFACT, UNDATED. IMAGE 2- AP RIGHT HIP FROM OCTOBER 26, 2018. ASSESSMENT OF IMAGING: ANATOMIC ALIGNMENT OF THE RIGHT HIP ARTHROPLASTY COMPONENTS WITHOUT DISLOCATION. EXTENSIVE ARTIFACT WAS NOTED ON THE UNDATED IMAGE. NO OTHER ANOMALIES WERE NOTED. IMPRESSIONS: ANATOMIC ALIGNMENT OF THE RIGHT HIP ARTHROPLASTY COMPONENTS. BONE QUALITY APPEARS NORMAL. NO EVIDENCE OF AVASCULAR NECROSIS OR OTHER ABNORMALITY. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. NO PRODUCT DOCUMENTATION WAS REVIEWED FOR INVESTIGATION. CONCLUSION SUMMARY: ACCORDING THE EVENT THE PATIENT UNDERWENT REVISION SURGERY OF THE RIGHT THR AFTER 2 MONTHS IN-VIVO TIME DUE TO DISLCOATION. HEAD AND LINER WERE REPLACED. NO PRODUCT WAS RETURNED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS FOR REPORTED COMPONENTS IDENTIFIED NO DEVIATIONS OR ANOMALIES THAT COULD CONTRIBUTE TO THE REPORTED EVENT. REVIEW OF SURGICAL TECHNIQUE WAS NOT PERFORMED AS NO SURGICAL TECHNIQUE WAS RECEIVED TO COMPARE. RECEIVED X-RAYS DO NOT REVEAL ANY DISLOCATION, SUBLUXATION OR INSTABILITY EVENT. THEREFORE, THE EVENT COULD NOT BE CONFIRMED. POSSIBLE REASONS LEADING DISLOCATION OF THE PROSTHESIS INCLUDE INCORRECT SEATING OF THE INSERT IN THE SHELL, LEG LAXITY OF THE PATIENT AND WRONG SELECTION OF THE IMPLANT. HOWEVER, BASED ON THE AVAILABLE INFORMATION, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE FOLLOWING REPORTS ARE ASSOCIATED WITH THIS EVENT: (B)(4) (WARSAW SPLIT CASE).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: - ITEM NUMBER 00801803202; ITEM NAME FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER; LOT # 63589465. - ITEM NUMBER 4245; ITEM NAME ALLOFIT ALLOCLASSIC SHELL 52/I I; LOT # 2945715. - ITEM NUMBER 0106010103; ITEM NAME AVENIR MULLER, STEM, LATERAL, UNCEMENTED, HA, 3, TAPER 12/14; LOT # 2817021. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. AS SOON AS SUPPLEMENTAL INFORMATION BECOMES AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO DUE TO INSTABILITY AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927822 DURASUL, ALPHA INSERT, II/32 ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS LZO ZIMMER GMBH N/A 2941733

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R