BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOCL SLL REVISION STEM 9 14

    MDR report key: 8905659 · Received August 19, 2019

    Report

    Report Number
    0009613350-2019-00509
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    March 2, 2004
    Report Date
    February 27, 2020
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K030373
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF INITIAL MEDWATCH. NEW INFORMATION RECEIVED: REF: 2889 LOT: 2084047 (ALLOCLASSIC SLL REV STEM 9). REF: 17.28.06 LOT: 2195779 (SULOXHEAD 28 M 12/14). REF: 426.2211 LOT: 2040241 (PEINSERT GAMMA KK/28 FLANGED). REF: 01.00044.010 LOT: 2187692 (ALLOCLAS VARIALL SHELL 54/KK). REASON FOR REVISION : PERIPROSTHETIC FRACTURE AND LOOSENING. IMPLANT POSITION : RIGHT. IMPLANTATION REPORT. REVISION REPORT. NO XRAY AVAILABLE. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING, A FOLLOW UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. ADDITIONAL: B3, H2, H6. CORRECTION: B4, B5, G4, G7, H10. DHR-REVIEW: REF#: 2889, LOT#: 2084047. YIELD: 10. DELIVERED: 9. SCRAPPED: 1. REASON FOR SCRAPPING: RIDGES IN SURFACE. THE DEVICE MANUFACTURING QUALITY RECORDS INDICATE THAT THE RELEASED COMPONENTS MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TREND HAS BEEN IDENTIFIED. EVENT DESCRIPTION: IT WAS REPORTED THAT AFTER TREATMENT WITH A DYNAMIC HIP SCREW, THE PATIENT WAS IMPLANTED ON (B)(6) 2004 WITH A TOTAL HIP PROTHESIS ON THE RIGHT HIP SIDE AND WAS REVISED ON (B)(6) 2004 DUE TO PERIPROSTHETIC FRACTURE AND STEM LOOSENING. REVIEW OF RECEIVED DATA: IMPLANTATION REPORT DATED (B)(6) 2004: DIAGNOSIS: HIP HEAD NECROSIS WITH SYNOVITIS AFTER FRACTURE AND TREATMENT WITH DYNAMIC HIP SCREW. PROCEDURE: TOTAL HIP PROCEDURE. CHISELING HAS TO BE PERFORMED IN ORDER TO REMOVE THE HIP SCREW. RATHER SOFT BONE IN ACETABULUM, THEREFORE OVERSIZING OF THE CUP IS DECIDED. NO COMPLICATIONS ARE NOTED. REVISION REPORT DATED (B)(6) 2004: DIAGNOSIS: PERIPROSTHETIC FRACTURE AND IMPLANT LOOSENING RIGHT HIP SIDE. PROCEDURE: STEM REVISION. NO COMPLICATIONS ARE NOTED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. CONCLUSION SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON (B)(6) 2004 WITH A TOTAL HIP PROTHESIS AND WAS REVISED ON (B)(6) 2004 DUE TO PERIPROSTHETIC FRACTURE AND LOOSENING OF THE STEM. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION FOR THE KNOWN LOT NUMBERS. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). AS NO X-RAYS HAVE BEEN RECEIVED, THE CORRECT SIZE OF IMPLANT FOR THE PATIENT CANNOT BE EVALUATED. MOREOVER, IT CANNOT BE DETERMINED WHETHER THE PREVIOUS BONE FRACTURE, WHICH WAS TREATED WITH A DYNAMIC HIP SCREW, HAS COMPLETELY HEALED YET. AN INCOMPLETE HEALING OF THE BONE MIGHT HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, 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. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THE REPORTED EVENT 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).

    Description of Event or Problem · 0

    IT WAS NOW REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TOPERIPROSTHETIC FRACTURE AND LOOSENING.

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    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. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS 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). ITEM AND LOT NUMBERS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION ON UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700356 ALLOCL SLL REVISION STEM 9 14 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM LZO ZIMMER GMBH N/A 2084047

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R