BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVENIR MUELLER STEM, LATERAL, UNCEMENTED, TAPER 12/14

    MDR report key: 12568563 · Received October 4, 2021

    Report

    Report Number
    0009613350-2021-00511
    Event Type
    Injury
    Date Received
    October 4, 2021
    Date of Event
    September 25, 2021
    Report Date
    November 26, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    UDI-DI
    00889024590922
    PMA / PMN Number
    K123392
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES BIOLOX DELTA HEAD, 12/14, 36X0 CATALOG#: 00-8775-036-02; LOT#: 3072057 D10: THERAPY DATE: (B)(6) 2021. INVESTIGATION RESULTS WERE MADE AVAILABLE. 1. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2021 AND HAD A REVISION SURGERY ON (B)(6) 2021 DUE TO A FALL EVENT, WHEREBY THE PATIENT FRACTURED THEIR HIP. HARM: S3 - BONE FRACTURE. HAZARDOUS SITUATION: PATIENT'S ANATOMY IS EXPOSED TO EXCESSIVE EXTERNAL FORCES POSTOPERATIVELY. 2. REVIEW OF RECEIVED DATA: NO MEDICAL DATA RELEVANT TO THE CASE HAS BEEN RECEIVED. DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. THE FOLLOWING SAP EXTRACTS TO THE INITIAL AND REVISION PROCEDURES WERE PROVIDED BY THE SALES REPRESENTATIVE: DEVICES USED DURING IMPLANTATION. SURGERY DESCRIPTION OF IMPLANTATION: RIGHT AVENIR CONTINUUM LTC. SURGERY DESCRIPTION OF REVISION SURGERY: RIGHT HIP NCB PP WITH GT ATTACHMENT ON STC FOR PERIPROSTHETIC FRACTURE. DEVICES USED DURING REVISION SURGERY. 3. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. REVIEW OF PRODUCT DOCUMENTATION: DEVICE PURPOSE: ALL INVOLVED DEVICES ARE INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE PRODUCT COMBINATION WAS APPROVED BY ZIMMER BIOMET. DHR REVIEW: NO NCR WITH A POTENTIAL CORRELATION TO THE REPORTED EVENT WAS FOUND. 5. CONCLUSION: IT WAS REPORTED THAT THE PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2021 AND HAD A REVISION SURGERY ON (B)(6) 2021 DUE TO A FALL EVENT, WHEREBY THE PATIENT FRACTURED THEIR HIP. THE QUALITY RECORDS SHOW THAT ALL SPECIFIED CHARACTERISTICS HAVE MET THE SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. THEREFORE, THE INVESTIGATION DID NOT IDENTIFY A NON-CONFORMANCE OR A COMPLAINT OUT OF BOX (COOB). NEITHER X-RAYS, OPERATIVE NOTES, OFFICE VISIT NOTES, NOR DEVICES OR PHOTOS OF THE DEVICES WERE RECEIVED; THEREFORE THE EXTENT OF THE PERIPROSTHETIC FRACTURE AS WELL AS THE CONDITION OF THE COMPONENTS IS UNKNOWN. BASED ON THE RECEIVED INFORMATION, THE REPORTED EVENT CANNOT BE CONFIRMED. THE REPORTED FALL EVENT HAS BEEN REPORTED AS BEING DIRECTLY CORRELATED WITH THE FRACTURE OF THIS HIP. THEREFORE, BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, THIS IS LIKELY TO BE THE ROOT CAUSE OF THE REPORTED EVENT OF PERIPROSTHETIC BONE FRACTURE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER SWITZERLAND MANUFACTURING GMBH CONSIDERS THIS CASE AS CLOSED. ZIMMER BIOMET'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT: BIOLOX DELTA HEAD, 12/14, 36X0 CATALOG#: 00-8775-036-02; LOT#: 3072057. THERAPY DATE: (B)(6) 2021. THE MANUFACTURER RECEIVED PHOTOGRAPHS AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR 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. 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

    IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471549 AVENIR MUELLER STEM, LATERAL, UNCEMENTED, TAPER 12/14 AVENIR MULLER STEM LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 2927103 00889024590922

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization| R SEE H10 NARRATIVE| SEE H10 NARRATIVE.