BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLOFIT CUP

    MDR report key: 11912970 · Received June 1, 2021

    Report

    Report Number
    0009613350-2021-00240
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    April 20, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    KWA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    1. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE IN THE YEAR 2017 AND UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE CUP. THE CUP AND HEAD WERE TO BE EXCHANGED, BUT DURING THE REVISION SURGERY THE CERAMIC HEAD GOT STUCK ONTO THE FITMORE STEM AND COULD NOT BE REMOVED. HARM: S3 - BONE MALUNION/NON-UNION, RESULTING IN REVISION OR OTHER INTERVENTIONS HAZARDOUS SITUATION: LOSS OF FIXATION OR NON-INTEGRATION OF AN IMPLANT. 2. REVIEW OF RECEIVED DATA: - DUE DILIGENCE: NO FURTHER DUE DILIGENCE REQUIRED AS ALL REQUIRED INFORMATION TO SUPPORT THE CONCLUSION IS AVAILABLE OR WAS ALREADY REQUESTED. 3. PRODUCT EVALUATION: - NO PRODUCT WAS RETURNED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATION COULD NOT BE PERFORMED. 4. 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. - DHR REVIEW: THE DHR CHECK COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE MISSING DEVICE INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE. AT ZIMMER SWITZERLAND MANUFACTURING GMBH ALL MEDICAL DEVICES PRIOR RELEASE TO MARKET UNDERGO SEVERAL QUALITY INSPECTIONS AS DEFINED IN OUR QUALITY PROCEDURES. OUR QUALITY INSPECTION- AND DEVIATION PROCEDURES ENSURE THAT ONLY PRODUCTS FULFILLING THE SPECIFICATION ARE SOLD. THESE PROCEDURES ARE PART OF THE OVERALL QUALITY MANAGEMENT SYSTEM AT ZIMMER SWITZERLAND MANUFACTURING GMBH AND GET REGULARLY AUDITED BY OUR NOTIFIED BODY, COMPETENT AUTHORITIES AND INTERNAL AND EXTERNAL AUDITORS. THUS, FOR ALL PRODUCTS SOLD TO THE MARKET CAN BE ASSUMED HAVING A COMPLETE AND CORRECT DHR. 5. CONCLUSION: IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED ON AN UNKNOWN DATE IN THE YEAR 2017 AND UNDERWENT A REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE CUP. THE CUP AND HEAD WERE TO BE EXCHANGED, BUT DURING THE REVISION SURGERY THE CERAMIC HEAD GOT STUCK ONTO THE FITMORE STEM AND COULD NOT BE REMOVED. INTRA-OPERATIVE COMPLICATION EVENT HAS BEEN RECORDED IN (B)(4). 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 GIVEN 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 (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION RESULTS ARE NOW AVAILABLE.

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 36/-3.5, TAPER 12/14; CATALOG#: 00-8775-036-01; LOT#: UNKNOWN. FITMORE STEM HIP IMPL WIN GEN; CATALOG#: UNKNOWN; LOT#: UNKNOWN. THERAPY DATE: UNKNOWN. THE MANUFACTURER DID NOT RECEIVE X-RAYS FOR REVIEW. OTHER DOCUMENTS WERE RECEIVED AND WILL BE REVIEWED AS PART OF ONGOING INVESTIGATION. THE MANUFACTURER DID NOT RECEIVE THE DEVICE FOR INVESTIGATION. 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. ZIMMER BIOMET¿S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED ON AN UNKNOWN SIDE AND UNDERWENT REVISION SURGERY DUE TO ASEPTIC LOOSENING OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809529 ALLOFIT CUP HIP PROSTHESIS KWA ZIMMER SWITZERLAND MANUFACTURING GMBH N/A UNKNOWN

    Patients

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