BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORIN OPTIMIZED POSITIONING SYSTEM

    MDR report key: 9442821 · Received December 9, 2019

    Report

    Report Number
    3012916784-2019-00028
    Event Type
    Injury
    Date Received
    December 9, 2019
    Report Date
    January 15, 2020
    Manufacturer
    CORIN AUSTRALIA PTY LTD
    Product Code
    LZO
    PMA / PMN Number
    K183038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT EXPERIENCED DISLOCATION, AND DURING RELOCATION THE FEMUR WAS FRACTURED. PATIENT WAS TRANSFERRED FROM A RURAL AREA TO ANOTHER HOSPITAL TO RECEIVE FURTHER TREATMENT. THE DATE OF FURTHER REINTERVENTION REGARDING THE FRACTURED FEMUR WAS UNABLE TO BE OBTAINED AS THE SURGEON THIS PATIENT WAS TRANSFERRED TO THE CARE OF WAS UNABLE TO BE CONFIRMED. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE PATIENT SUFFERED FROM MULTIPLE COMORBIDITIES THAT LIMITED THE OPS PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY, AND WAS DETERMINED TO BE A DIFFICULT PRIMARY AND AN ASA RATING OF III (SEVERE SYSTEMATIC DISEASE). A ROOT CAUSE INVESTIGATION WAS CONDUCTED INTO THIS EVENT. ALL OPERATIONS IN THE PROCESSING OF THE PRE-OPERATIVE PLANNING WERE CONFIRMED TO HAVE BEEN COMPLETED ACCORDING TO WORK INSTRUCTIONS AND THE PRODUCTS PROVIDED TO THE SURGERY WERE CONFIRMED TO BE MANUFACTURED TO SPECIFICATION. THERE WAS INSUFFICIENT INFORMATION TO DETERMINE IF THE USE OF OPS TECHNOLOGY WAS INVOLVED IN THIS REVISION EVENT. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    PATIENT EXPERIENCED DISLOCATION, AND DURING RELOCATION THE FEMUR WAS FRACTURED. PATIENT WAS TRANSFERRED FROM A RURAL AREA TO ANOTHER HOSPITAL TO RECEIVE FURTHER TREATMENT. THE DATE OF FURTHER REINTERVENTION REGARDING THE FRACTURED FEMUR WAS UNABLE TO BE OBTAINED AS THE SURGEON THIS PATIENT WAS TRANSFERRED TO THE CARE OF WAS UNABLE TO BE CONFIRMED. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE PATIENT SUFFERED FROM MULTIPLE COMORBIDITIES THAT LIMITED THE OPS PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY, AND WAS DETERMINED TO BE A DIFFICULT PRIMARY AND AN ASA RATING OF III (SEVERE SYSTEMATIC DISEASE). A ROOT CAUSE INVESTIGATION WAS CONDUCTED INTO THIS EVENT. ALL OPERATIONS IN THE PROCESSING OF THE PRE-OPERATIVE PLANNING WERE CONFIRMED TO HAVE BEEN COMPLETED ACCORDING TO WORK INSTRUCTIONS AND THE PRODUCTS PROVIDED TO THE SURGERY WERE CONFIRMED TO BE MANUFACTURED TO SPECIFICATION. THERE WAS INSUFFICIENT INFORMATION TO DETERMINE IF THE USE OF OPS TECHNOLOGY WAS INVOLVED IN THIS REVISION EVENT. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Additional Manufacturer Narrative · 1

    PATIENT EXPERIENCED DISLOCATION, AND DURING RELOCATION THE FEMUR WAS FRACTURED. PATIENT WAS TRANSFERRED FROM A RURAL AREA TO ANOTHER HOSPITAL TO RECEIVE FURTHER TREATMENT. THE DATE OF FURTHER REINTERVENTION REGARDING THE FRACTURED FEMUR WAS UNABLE TO BE OBTAINED AS THE SURGEON THIS PATIENT WAS TRANSFERRED TO THE CARE OF WAS UNABLE TO BE CONFIRMED. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE PATIENT SUFFERED FROM MULTIPLE COMORBIDITIES THAT LIMITED THE OPS PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY, AND WAS DETERMINED TO BE A DIFFICULT PRIMARY AND AN ASA RATING OF III (SEVERE SYSTEMATIC DISEASE). THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    PATIENT EXPERIENCED DISLOCATION, AND DURING RELOCATION THE FEMUR WAS FRACTURED. PATIENT WAS TRANSFERRED FROM A RURAL AREA TO ANOTHER HOSPITAL TO RECEIVE FURTHER TREATMENT. THE DATE OF FURTHER REINTERVENTION REGARDING THE FRACTURED FEMUR WAS UNABLE TO BE OBTAINED AS THE SURGEON THIS PATIENT WAS TRANSFERRED TO THE CARE OF WAS UNABLE TO BE CONFIRMED. PATIENT RECEIVED THE USE OF THE OPS PLAN (K183038), PATIENT SPECIFIC ACETABULAR GUIDE (K152893), PATIENT SPECIFIC FEMORAL GUIDE (K181061), AND DHA REPORT IN THE PRIMARY SURGERY. THE DYNAMIC HIP ANALYSIS (DHA) REPORT IS NOT AVAILABLE ON THE US MARKET, HOWEVER THE SIMILAR PRODUCT FUNCTIONAL HIP ANALYSIS (FHA) REPORT (K152893) IS AVAILABLE ON THE US MARKET. THE PATIENT SUFFERED FROM MULTIPLE COMORBIDITIES THAT LIMITED THE OPS PRE-OPERATIVE PLANNING PROVIDED TO THE PRIMARY SURGERY, AND WAS DETERMINED TO BE A DIFFICULT PRIMARY AND AN ASA RATING OF III (SEVERE SYSTEMATIC DISEASE). THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229981 CORIN OPTIMIZED POSITIONING SYSTEM HIP PROSTHESIS LZO CORIN AUSTRALIA PTY LTD 1248-1500 BRA_DK_19865

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization