BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14

    MDR report key: 7133279 · Received December 20, 2017

    Report

    Report Number
    0009613350-2017-01769
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    May 25, 2015
    Report Date
    June 12, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK073567
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: STEM, ITEM#UNKNOWN, LOT#UNKNOWN. SHELL POROUS WITH MULTI HOLES 60 MM, ITEM#00620206020, LOT#62819275; MANUFACTURED BY ZIMMER INC., WARSAW. BONE SCREW SELF-TAPPING 6.5 MM DIA. 30 MM LENGTH, ITEM#00625006530, LOT#62803360; MANUFACTURED BY ZIMMER INC., WARSAW. BONE SCREW SELF-TAPPING 6.5 MM DIA. 35 MM LENGTH, ITEM#00625006535, LOT#62836982; MANUFACTURED BY ZIMMER INC., WARSAW. BONE SCREW SELF-TAPPING 6.5 MM DIA. 60 MM LENGTH, ITEM#00625006560, LOT#62448819; MANUFACTURED BY ZIMMER INC., WARSAW. LINER 10 DEGREE ELEVATED RIM 3.5 MM OFFSET 36 MM I.D. FOR USE WITH 60 MM O.D. SHELL, ITEM#00631006036, LOT#62738401; MANUFACTURED BY ZIMMER INC., WARSAW. DEVICE HISTORY RECORDS (DHR): 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 (EVENT DETAILS, PER) EVENT SUMMARY: PATIENT HAD UNDERWENT REVISION SURGERY ON (B)(6) 2015 TO EXCHANGE DUROM WITH MULTI HOLE CUP - BIOLOX HEAD. SUBSEQUENTLY ON (B)(6) 2015 PATIENT UNDERWENT SECOND REVISION TO REMOVE ALL IMPLANTS DUE TO DISLOCATION. REVIEW OF RECEIVED DATA IMPLANTATION SURGERY REPORT DATED (B)(6) 2015: REVISION SURGERY DUE TO METAL WEAR. CUP IS REMOVED. TRABECULAR METAL CUP WAS IMPLANTED AT 45 DEGREES INCLINATION WITH SCREWS. PE LINER 10° ELEVATED RIM WAS INSERTED. FEMORAL COMPONENTS REMOVED. ZIMMER STEM IMPLANTED. 6MM BIOLOX CERAMIC HEAD 12/14 WAS POSITIONED ON THE STEM. EXCELLENT STABILITY ACHIEVED. NO ABNORMLATIES OBSERVED. REVISION SURGERY REPORT DATED MAY 25, 2015: PREOPERATIVE DIAGNOSIS: DISLOCATION OF THE RIGHT HIP. NO SUSPICION OF INFECTION IS NOTED. TROCHANTER WAS ALREADY TORN DUE TO DISLOCATION. ALL THE COMPONENTS WERE REMOVED. STRYKER DOUBLE MOBILITY CUP WITH SCREW AT 45°. ZIMMER STEM 12/14 IS IMPLANTED. 28 +7 HEAD WITH A 48MM POLYETHYLENE DOUBLE MOBILITY INSERT POSITIONED. REDUCTION IS MADE. STABILITY WAS SATISFYING. NO PROMBLEMS WERE NOTICED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS, ACCORDING TO THE INFORMATION RECEIVED THE DEVICE LOCATION IS UNKNOWN. REVIEW OF PRODUCT DOCUMENTATION: THE IMPLANTED STEM IS UNKNOWN. NO COMPATIBILITY TEST COULD BE DONE FOR THAT. HOWEVER, THE CERAMIC HEAD AND THE PE LINER COMBINATION IS ALLOWED. ROOT CAUSE ANALYSIS: ROOT CAUSE DETERMINATION USING DFMEA: DISLOCATION (SHORT-TERM MANIFESTATION OF HARM) DUE TO USER ERROR - JOINT LAXITY POSSIBLE: NO INFORMATION ABOUT THE JOINT LAXITY OF THE PATIENT IS AVAILABLE, THEREFORE CANNOT BE EXCLUDED. DISLOCATION (SHORT-TERM MANIFESTATION OF HARM) DUE TO JOINT LAXITY DUE TO LIMITED HEAD OFFSET OPTIONS POSSIBLE: NO INFORMATION ABOUT THE JOINT LAXITY OF THE PATIENT IS AVAILABLE, THEREFORE CANNOT BE EXCLUDED. DISLOCATION (SHORT-TERM MANIFESTATION OF HARM) DUE TO NO OR INADEQUATE LABELING - SURGEON SELECTS INCORRECT HEAD OFFSET POSSIBLE: THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION, THEREFORE, THE CORRECT LABELING CANNOT BE CONFIRMED. WEAR (BETWEEN HEAD/ADAPTER/STEM JUNCTIONS) DUE TO USER ERROR - OFF LABEL USE (INCLUDING COMPETITOR PRODUCT) POSSIBLE: STEM IS UNKNOWN, THEREFORE CANNOT BE EXCLUDED. CONCLUSION SUMMARY ACCORDING TO THE REPORTED EVENT, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISLOCATION OF THE HIP AFTER 2 MONTHS IN-VIVO TIME. BIOLOX OPTION HEAD AND ALL OTHER COMPONENTS WERE REVISED. NO X-RAYS BELONGING TO THE TIME INTERVAL OF THE COMPLAINT WERE AVAILABLE FOR REVIEW. REVISION SURGERY REPORT REVIEW SHOWED NO STATEMENT TO HINT AT ANY POSSIBLE ROOT CAUSE FOR THE EVENT. HOWEVER, REMOVAL OF NEWLY IMPLANTED CUP INDICATES THAT POSSIBLY THE CUP WAS LOOSE OR IT WAS NOT STABLE, WHICH COULD HAVE LED TO THE OBSERVED DISLOCATION EVENT. MOREOVER SURGICAL REPORT SHOWS THAT THE CLS STEM WAS ALSO REVISED DURING THE OP IN MAR, 2015. HOWEVER, NO IDENTIFICATION INFORMATION ABOUT THE NEW IMPLANTED STEM IS REPORTED. THEREFORE, THE MOST POSSIBLE REASON OF THE DISLOCATION EVENT IS THE INSTABILITY OF THE ACETABULAR COMPONENTS. OTHER POSSIBLE REASONS INCLUDE NOT BALANCED TISSUE TENSION, WRONG HEAD OFFSET DETERMINATION, LEG LENGTH DISCREPANCY, WRONG POSITIONING OF THE COMPONENTS AND NOT ALLOWED COMBINATION WITH STEM. HOWEVER, AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER BIOMET CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    A PATIENT IS PURSUING A PRODUCT LIABILITY CLAIM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14 ON THE RIGHT SIDE ON (B)(6) 2015 AND THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015 DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914385 BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14 BIOLOX OPTION HEAD LZO ZIMMER GMBH N/A 2782632

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R