BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAGNER SL REVISION HIP STEM, UNCEMENTED, 18/265, TAPER 12/14

    MDR report key: 8615259 · Received May 16, 2019

    Report

    Report Number
    0009613350-2019-00311
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    February 5, 2019
    Report Date
    November 25, 2019
    Manufacturer
    ZIMMER GMBH
    Product Code
    LZO
    PMA / PMN Number
    K043356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. DHR REVIEW: THE QUALITY RECORDS INDICATE THAT THIS COMPONENT MET ALL REQUIREMENTS TO PERFORM AS INTENDED. TREND ANALYSIS: NO TRIGGER CONSIDERING THE FOLLOWING EVENT IS IDENTIFIED: DISLOCATION NO LOT TRIGGER: NO SIMILAR INVESTIGATED EVENTS FOR THE SAME LOT NUMBER 2934288 HAVE BEEN FOUND. REVIEW OF EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 AND RECEIVED ZB DEVICES. SUBSEQUENTLY, ON (B)(6) 2019, THE PATIENT DISLOCATED HER HIP AND WAS REDUCED UNDER GENERAL ANESTHESIA. ON (B)(6) 2019 PATIENT DISLOCATED HER HIP AGAIN AND WAS REVISED ON (B)(6) 2019 AFTER A THIRD DISLOCATION. THE WAGNER SL STEM WAS EXPLANTED TOGETHER WITH LINER AND HEAD. REVIEW OF RECEIVED DATA: RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: MMI IMAGE (B)(6) 2019 POST-CONVERSION FROM GIRDLESTONE TO G7: LEFT TOTAL HIP ARTHROPLASTY WITH SURGICAL SKIN STAPLES AND SCREW FIXATION OF THE ACETABULAR CUP. FRACTURED GREATER TROCHANTER WITH PROXIMAL CERCLAGE WIRE AND AGE-INDETERMINATE FRACTURE INVOLVING THE LESSER TROCHANTER (COULD POSSIBLY BE A RESULT OF GIRDLESTONE PROCEDURE FOR INFECTION OR CONVERTING FROM GIRDLESTONE TO G7 PRODUCT). MMI IMAGE (B)(6) 2019 : LEFT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION. THE ACETABULAR CUP WITH SURGICAL SKIN STAPLES. SUPERIOR DISLOCATION OF THE FEMORAL HEAD. HEALING FRACTURE OF THE LESSER TROCHANTER, WITH A DISPLACED FRACTURE OF THE GREATER TROCHANTER. ONE PROXIMAL CERCLAGE WIRE. MMI IMAGE (B)(6) 2019: 2 IMAGES OF THE LEFT HIP DEMONSTRATE A LEFT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION OF THE ACETABULAR CUP. MMI IMAGE (B)(6) 2019: LEFT TOTAL HIP ARTHROPLASTY WITH SCREW FIXATION OF THE ACETABULAR CUP. SUPERIOR DISLOCATION. LUCENT LINE ALONG THE LESSER TROCHANTER SUGGESTS A POSSIBLE FRACTURE. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: INITIAL SURGERY DATE MEDICAL NOTES WERE NOT PROVIDED. REVISION GRIDLESTONE OPERATION NOTES WERE NOT PROVIDED. REVISION OP NOTES DATED 28 JAN 2019 WERE NOT PROVIDED. REVISION NOTES 29 MAR 2019 WERE REVIEWED AND IDENTIFIED PATIENT WAS REVISED DUE TO DISLOCATION WHILE TURNING IN THE BED. EVACUATION OF HEMATOMA WAS PERFORMED. NO SIGNS OF ONGOING INFECTION. TWO CERCLAGE WIRES PLACED TO SECURE THE TROCHANTER AS IT WAS NOTED FRACTURED. DEVICES ANALYSIS: NO PRODUCT WAS RETURNED TO ZIMMER BIOMET FOR IN-DEPTH ANALYSIS. REVIEW OF PRODUCT DOCUMENTATION: THIS DEVICE IS INTENDED FOR TREATMENT. THE COMPATIBILITY CHECK WAS PERFORMED AND SHOWED THAT THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. SURGICAL TECHNIQUE OF WAGNER SL REVISION HIP STEM WAS NOT REVIEWED AS NO SURGICAL REPORT OF REVISION SURGERY DATED JAN 28, 2019 WAS RECEIVED TO CONFIRM WHETHER THE ST WAS FOLLOWED OR NOT. INSTRUCTION FOR USE (IFU): IN THE IFU DISLOCATION AND SUBLUXATION IS INDICATED AS ADVERSE EFFECT. COMPLAINT SUMMARY: BASED ON THE RECEIVED X-RAYS THIS COMPLAINT CAN BE CONFIRMED. ACCORDING TO THE PROVIDED DATA THE PATIENT WAS IMPLANTED WITH A WAGNER SL STEM ON (B)(6) 2019. ON (B)(6) 2019 THE WAGNER STEM WAS REVISED DUE TO RECURRENT DISLOCATIONS. ONLY 8 DAYS AFTER REVISION SURGERY THE HIP DISLOCATED AND A CLOSED REDUCTION WAS PERFORMED UNDER LOCAL ANESTHESIA. SIX WEEKS LATER, ON (B)(6) 2019, DURING TAKING X-RAYS THE PATIENT DISLOCATED HER HIP AGAIN AND UNDERWENT A CLOSED REDUCTION UNDER GENERAL ANESTHESIA. AFTER THIRD DISLOCATION A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 WERE LINER, HEAD AND STEM WERE REVISED. THE QUALITY RECORDS SHOW THAT THE SPECIFIED CHARACTERISTICS OF THE WAGNER SL STEM (MATERIAL, DIMENSIONS, SURFACE, ETC.) HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THE INVESTIGATION RESULTS DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: 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).

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE PREVIOUS MEDWATCH. ADDITIONAL AND CORRECTED INFORMATION ARE FILLED IN THE FOLLOWING FIELDS: MEDICAL PRODUCTS AND THERAPY DATE DETAIL OF PRODUCT: - ASSOCIATED ITEM NUMBER 110024465, ITEM NAME G7 DUAL MOBILITY LINER 46MM G, LOT # 143090. - ITEM NUMBER EP-200152, ITEM NAME ACT ARTIC E1 HIP BRG 28X46MM S52 DIA28. LOT # 490510. - ITEM NUMBER 010000666, ITEM NAME G7 PPS LTD ACET SHELL 58G, LOT # 6320695. - ITEM NUMBER 00801802802, ITEM NAME FEMORAL HEAD STERILE PRODUCT DO NOT RESTERILIZE 12/14 TAPER, LOT # 64003482. 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 · 0

    NO EVENT UPDATE.

    Description of Event or Problem · 0

    PATIENT WAS IMPLANTED ON LEFT SIDE AND UNDERWENT REVISION DUE TO MULTIPLE DISLOCATIONS. DURING REVISION SURGERY A FRACTURED LESSER TROCHANTER WAS NOTICED AND 300 ML HEMATOMA WAS DRAINED; NO SIGNS OF ONGOING INFECTION. ATTEMPTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE BUT ARE NOT AVAILABLE AT THIS POINT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER RECEIVED X-RAYS AND OTHER SOURCE DOCUMENTS FOR REVIEW. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. WHERE LOT NUMBERS WERE RECEIVED FOR THE EXPLANTED 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. 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

    PATIENT WAS IMPLANTED ON LEFT SIDE AND UNDERWENT REVISION DUE TO MULTIPLE DISLOCATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411483 WAGNER SL REVISION HIP STEM, UNCEMENTED, 18/265, TAPER 12/14 WAGNER SL REVISION, L265 MM, 18MM LZO ZIMMER GMBH N/A 2934288

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R