BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 6, TAPER 12/14

    MDR report key: 7236549 · Received February 2, 2018

    Report

    Report Number
    0009613350-2018-00217
    Event Type
    Injury
    Date Received
    February 2, 2018
    Date of Event
    June 21, 2016
    Report Date
    August 3, 2018
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    PK033664
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL: H2, H6 CORRECTION: A2, B4, F10, G4, G7, H10 DEVICE HISTORY RECORDS (DHR): THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. A TREND CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: POSTIMPLANTATION PERIPROSTHETIC BONE FRACTURE. FURTHER INVESTIGATION HAS BEEN PERFORMED, SEE CONCLUSION. EVENT SUMMARY: NJR INFORMED ZIMMER BIOMET ABOUT CERTAIN PATIENT'S EXPERIENCES WITH ALLOCLASSIC SL STEMS RESULTED IN REVISION SURGERIES. THE CASE AT HAND TREATS THE EXPERIENCE OF A 81 YEARS OLD MALE PATIENT. THE PATIENT WAS REVISED 10 YEARS POST IMPLANTATION DUE TO PERIPROSTHETIC BONE FRACTURE. THE FOLLOWING CASES WERE FILED ACCORDING REVIEW OF RECEIVED DATA: NO MEDICAL DATA SUCH AS X-RAYS, SURGICAL NOTES OR ANY OTHER CASE-RELEVANT DOCUMENTS RECEIVED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THE COMPATIBILITY CHECK WAS PERFORMED FROM WWW.PRODUCTCOMPATIBILITY.ZIMMER.COM AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. ROOT CAUSE ANALYSIS ROOT CAUSE DETERMINATION USING RMW: - ASEPTIC LOOSENING OF STEM, BONE FRACTURE DUE TO INSUFFICIENT PRIMARY STABILITY DUE TO DESIGN NOT POSSIBLE -> A SYSTEMATIC ISSUE WITH DESIGN WOULD HAVE BEEN DETECTED AS PART OF THE ISSUE EVALUATION ASSESSMENT. - IMPLANT BREAKAGE, BONE FRACTURE DUE TO WRONG PLANNING TEMPLATE USED / MISINTERPRETATION OF THE X-RAY TEMPLATES REGARDING CENTER OF ROTATION/LEG LENGTH/OFFSET => POSSIBLE, SINCE IT IS UNKNOWN IF PLANNING OF THE SURGERY WAS PERFORMED ACCORDING TO SURGICAL TECHNIQUE. NO SURGICAL REPORT AND NOT X-RAY AVAILABLE FOR REVIEW. THEREFORE, THIS CAUSE CANNOT BE EXCLUDED. CONCLUSION SUMMARY IT WAS REPORTED BY NJR THAT A PATIENT EXPERIENCED A PERIOPROSTHETIC BONE FRACTURED AROUND 10 YEARS POST-IMPLANTATION AND UNDERWENT THEREFORE A REVISION SURGERY. NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR THE DEVICE OR PHOTOS OF THE EXPLANTED IMPLANT WERE RECEIVED; THEREFORE THE CONDITION OF THE COMPONENT IS UNKNOWN. PATIENT FACTORS THAT MAY AFFECT THE PERFORMANCE OF THE COMPONENTS SUCH AS BONE QUALITY, ACTIVITY LEVEL, TYPE OF ACTIVITY (LOW IMPACT VS. HIGH IMPACT), AND RELEVANT MEDICAL HISTORY ARE UNKNOWN. ADHERENCE TO REHABILITATION PROTOCOL IS UNKNOWN. IN CONCLUSION, DUE TO SIGNIFICANT LACK OF INFORMATION, IT IS IMPOSSIBLE TO PERFORM A MEANINGFUL ANALYSIS OF THE REPORTED EVENT. THEREFORE, AN EXACT ROOT CAUSE CANNOT BE DETERMINED. THE RISK OF BONE FRACTURE AFTER IMPLANTATION IS A KNOWN RISK AND IS ADDRESSED IN RMW. THE OCCURRENCE RATE FOR FAILURE MODE ¿PERIPROSTHETIC BONE FRACTURE¿ WAS CALCULATED. IN TOTAL 4 SIMILAR COMPLAINTS HAVE BEEN FOUND. THE OCCURRENCE RATE WAS ASSESSED AS ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION AT THIS POINT OF TIME FURTHER ACTIONS ARE NOT DEEMED NECESSARY. 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).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ITEM: SHELL POROUS WITH HOLES 56 MM O.D., CATALOG #: 00-6200-056-20, LOT #: 60331125. ITEM: LINER 32 MM I.D. FOR USE WITH 56 MM O.D., CATALOG #: 00-6110-056-32, LOT #: 60302393. ITEM: COCR HEAD 32/ 0 'M' 12/14, CATALOG #: 14.32.06-20, LOT #: 2314115. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. THE MANUFACTURER DID NOT RECEIVE X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW. THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. 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

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION SURGERY APPROXIMATELY TEN YEARS POST IMPLANTATION DUE TO PERIPROSTHETIC FRACTURE (STEM). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS CURRENTLY NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82183 ALLOCLASSIC, SL STEM, OFFSET, UNCEMENTED, 6, TAPER 12/14 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM LZO ZIMMER GMBH N/A 2303173

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R