BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLS STEM

    MDR report key: 10117959 · Received June 4, 2020

    Report

    Report Number
    0009613350-2020-00233
    Event Type
    Injury
    Date Received
    June 4, 2020
    Report Date
    March 26, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    LZO
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS WERE MADE AVAILABLE. EVENT DESCRIPTION: PRODUCT WAS IMPLANTED ON UNKNOWN DATE. IMPLANT INQUIRY WAS MADE AS PART OF SURGERY PRE-PLANNING DUE TO PERIPROSTHETIC FRACTURE. IT WAS DETERMINED, THAT THE STEM MIGHT EITHER BE A STELKAST DTW OR A ZIMMER CLS. HARM: S3 - BONE FRACTURE. HAZARDOUS SITUATION: PATIENT'S ANATOMY IS EXPOSED TO EXCESSIVE EXTERNAL FORCES POSTOPERATIVELY. REVIEW OF RECEIVED DATA: DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS FOLLOW-UPS WERE ALREADY PERFORMED, HOWEVER, NO INFORMATION COULD BE OBTAINED. X-RAYS: BASED ON THE RECEIVED UNDATED X-RAY, IT CAN BE CONFIRMED THAT THE PATIENT'S BONE IS FRACTURED. PRODUCT EVALUATION: NO PRODUCT WAS RETURNED FOR AN INVESTIGATION. NO INFORMATION IS AVAILABLE, THAT THE REVISION SURGERY HAS BEEN PERFORMED. REVIEW OF PRODUCT DOCUMENTATION: DOCUMENT REVIEW COULD NOT BE PERFORMED DUE TO UNKNOWN PRODUCT IDENTIFICATION. DEVICE PURPOSE: THIS DEVICE IS INTENDED FOR TREATMENT. PRODUCT COMPATIBILITY: THE COMPATIBILITY CHECK COULD NOT BE PERFORMED DUE TO MISSING PRODUCT IDENTIFICATION. CONCLUSION: PRODUCT WAS IMPLANTED ON UNKNOWN DATE. IMPLANT INQUIRY WAS MADE AS PART OF SURGERY PRE-PLANNING DUE TO PERIPROSTHETIC FRACTURE. IT WAS DETERMINED, THAT THE STEM MIGHT EITHER BE A STELKAST DTW OR A ZIMMER CLS. BASED ON THE INVESTIGATION THE REPORTED EVENT CAN BE CONFIRMED. THE RECEIVED X-RAY CONFIRMS THE PERIPROSTHETIC BONE FRACTURE. DUE TO SIGNIFICANT LACK OF INFORMATION A DETAILED INVESTIGATION COULD NOT BE PERFORMED, NEVERTHELESS BASED ON THE GIVEN INFORMATION THERE IS NO INDICATION OF A NON-CONFORMANCE OR COMPLAINT OUT OF BOX (COOB). BASED ON THE LIMITED AVAILABLE INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. 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

    CONCOMITANT MEDICAL PRODUCT: UNKNOWN CUP, CATALOG#: UNKNOWN; LOT#: UNKNOWN. THERAPY DATE: UNKNOWN. THE MANUFACTURER RECEIVED X-RAY AND SOURCE DOCUMENTS FOR REVIEW. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND AN IMPLANT ENQUIRY WAS MADE AS A PART OF SURGERY PRE-PLANNING TO TREAT PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583147 CLS STEM CLS STEM LZO ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization SEE H10 NARRATIVE.