BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR HEAD 32/ 0 'M' 12/14

    MDR report key: 6401893 · Received March 14, 2017

    Report

    Report Number
    0009613350-2017-00370
    Event Type
    Injury
    Date Received
    March 14, 2017
    Date of Event
    February 21, 2017
    Report Date
    March 14, 2017
    Manufacturer
    ZIMMER GMBH
    Product Code
    LPH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID RECEIVE SOURCE DOCUMENTS WHICH WILL BE REVIEWED AS PART OF THE ONGOING INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4). THE ACTUAL DEVICE REPORTED IS NOT MARKETED IN USA, BUT DEVICES WITH SIMILAR CHARACTERISTICS (I.E COCR HEAD 40MM 12/14 SZM/0) ARE MARKETED IN USA, AND THEREFORE THIS REPORT WAS FILED.

    Additional Manufacturer Narrative · 1

    TREND ANALYSIS: NO TREND IDENTIFIED. DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A CONCESSION WAS FOUND THAT HAS NO EFFECT ON THE EFFECTIVENESS OF THE PRODUCT. EVENT SUMMARY: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A COCR HEAD AND A WARSAW LINER ON LEFT HIP SIDE ON (B)(6) 2008 AS A REVISION DUE TO DISLOCATION OF AN ORIGINAL UNKNOWN IMPLANT. LATER, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2017 DUE TO DISLOCATION OF THE CONSTRAINED LINER. LINER AND HEAD WERE REVISED. SPLIT CASE FOR THE LINER, AS IT IS MANUFACTURED BY ZIMMER INC, WARSAW IS (B)(4). REVIEW OF RECEIVED DATA: ONE X-RAY OF THE LEFT THA DATED (B)(6) 2017 WAS RECEIVED FOR THE REVIEW. IT IS OBSERVED THAT THE FEMORAL COMPONENT OF THE THA IS DECENTRALIZED. THE HEAD IS SEEN TO BE NOT ANYMORE LOCATED IN THE ACETABULAR CUP. METAL RING OF THE LINER IS NOTICED TO BE DETACHED AND MIGRATED ALONG WITH THE FEMORAL COMPONENT. ONE PHOTO OF THE EXPLANTED DEVICES WAS RECEIVED. ALL THE EXPLANTED COMPONENTS ARE COVERED WITH BLOOD. THE LINER IS SEEN TO BROKEN INTO SOME SMALLER FRAGMENTS AND THE METAL RING IS DETACHED FROM THE LINER. IT IS NOT POSSIBLE TO SEE SIGNIFICANT DEFORMATION EXISTING ON THE COCR HEAD EXCEPT SOME AREAS LOOKING LIKE POLISHED, HOWEVER, THIS CANNOT BE CONFIRMED . IMPLANT STICKERS OF THE SURGERY DATED (B)(6) 2008 WERE RECEIVED. IT IS SEEN THAT THE SURGERY WAS THE REVISION OF THE PREVIOUS THA AND ONLY THE HEAD AND LINER WERE REVISED. ADDITIONALLY, SURGICAL PROCEDURE CHART DATED (B)(6) 2008 WAS AVAILABLE FOR REVIEW, HOWEVER, NO VALUABLE INFORMATION COULD BE EXTRACTED. NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS, THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION (TRILOGY CONSTRAINED LINER AND COCR HEAD 32MM) WAS NOT APPROVED BY ZIMMER BIOMET. ROOT CAUSE DETERMINATION USING DFMEA: INCREASED RELEASE OF WEAR PARTICLES, DYSFUNCTION OF JOINT DUE TO DISLOCATION, SUBLUXATION DUE TO SOFT TISSUE LAXITY => POSSIBLE: NO INFO REGARDING THE LAXITY IS GIVEN, THEREFORE CANNOT BE EXCLUDED. INCREASED CHEMICAL, GALVANIC OR CREVICE CORROSION AND / OR FRETTING OF MATERIAL, METAL ION RELEASE DUE TO NOT ALLOWED / WRONG COMBINATION OF ZIMMER PRODUCTS => POSSIBLE: COMBINATION OF THE LINER AND THE HEAD IS NOT APPROVED. CONCLUSION SUMMARY: THE RECEIVED X-RAY INDICATES THE METAL RING WAS DETACHED FROM THE WARSAW CONSTRAINED LINER. IT IS ASSUMED THAT THIS DETACHMENT SUBSEQUENTLY LED TO THE DISLOCATION OF THE HEAD. IT IS NOT KNOWN AT WHICH TIME THE FEMORAL COMPONENT OF THE THA LOST CONNECTION WITH THE ACETABULAR COMPONENT. POSSIBLE REASONS OF THE REPORTED FAILURE INCLUDE SOFT TISSUE LAXITY OF THE PATIENT AND NOT ALLOWED COMBINATION OF ZIMMER PRODUCTS. THE INVESTIGATION OF THE CONSTRAINED LINER IS COVERED IN SPLIT CASE ZIMMER INC, WARSAW (B)(4). BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE COULD IDENTIFY A ROOT CAUSE FOR THE ISSUE. THE ROOT CAUSE IS USE ERROR - INAPPROPRIATE COMBINATION OF PRODUCT SINCE THE COCR HEAD 32MM WAS COMBINED WITH A TRILOGY CONSTRAINED LINER. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A COCR HEAD 32/ 0 'M' 12/14 ON LEFT HIP SIDE ON (B)(6) 2008 AND UNDERWENT REVISION ON (B)(6) 2017 DUE TO DISLOCATION. NOTE: THIS IS A SPLIT CASE WITH ZIMMER, INC, (B)(4), REFERENCE NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185749 COCR HEAD 32/ 0 'M' 12/14 UNKNOWN LPH ZIMMER GMBH N/A 2450735

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R