BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRINITY

    MDR report key: 8239920 · Received January 11, 2019

    Report

    Report Number
    9614209-2019-00003
    Event Type
    Injury
    Date Received
    January 11, 2019
    Date of Event
    August 14, 2019
    Report Date
    January 11, 2019
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER -1785 COMBINED REPORT. A COMBINED REPORT FOR THIS CASE WAS SUBMITTED ON (B)(6 )2019, HOWEVER, IN ERROR IT DID NOT CONTAIN THE DATE IN WHICH THE MANUFACTURER BECAME AWARE OF THE EVENT. THIS INFORMATION HAS NOW BEEN INCLUDED IN THIS REPORT. A TRINITY CUP AND METAFIX STEM WERE REVISED DURING PRIMARY SURGERY DUE TO INTRA-OPERATIVE COMPLICATIONS. CORIN HAS NOT RECEIVED ANY INFORMATION REGARDING WHAT THE COMPLICATIONS WERE AND THERE IS NO EVIDENCE TO SUGGEST THAT THERE HAS BEEN A MALFUNCTION OR FAULT WITH THE CORIN DEVICES. X-RAYS, OPERATIVE NOTES AND THE EXPLANTED DEVICES WERE NOT AVAILABLE AND THUS THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THIS INVESTIAGTION. THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. BASED ON THE INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THUS CORIN NOW CONSIDER THIS CASE CLOSED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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. THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    A TRINITY CUP AND METAFIX STEM WERE REVISED DURING A PRIMARY SURGERY DUE TO INTRA-OPERATIVE COMPLICATIONS. CORIN HAS NOT RECEIVED ANY INFORMATION REGARING WHAT THE COMPLICATIONS WERE, HOWEVER, IT HAS BEEN STATED THAT THE CORIN CUP AND STEM WERE NOT AT FAULT FOR THE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4) COMBINED REPORT. A TRINITY CUP AND METAFIX STEM WERE REVISED DURING PRIMARY SURGERY DUE TO INTRA-OPERATIVE COMPLICATIONS. CORIN HAS NOT RECEIVED ANY INFORMATION REGARDING WHAT THE COMPLICATIONS WERE AND THERE IS NO EVIDENCE TO SUGGEST THAT THERE HAS BEEN A MALFUNCTION OR FAULT WITH THE CORIN DEVICES. X-RAYS, OPERATIVE NOTES AND THE EXPLANTED DEVICES WERE NOT AVAILABLE AND THUS THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THIS "INVESTIAGTION". THE APPROPRIATE DEVICE DETAILS WERE PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. ALL PARTS ASSOCIATED WITH THESE RECORDS CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION AT THE TIME OF MANUFACTURE. BASED ON THE INFORMATION AVAILABLE, NO FURTHER INVESTIGATION CAN BE CONDUCTED AND THUS CORIN NOW CONSIDER THIS CASE CLOSED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED THEN THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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

    A TRINITY CUP AND METAFIX STEM WERE REVISED DURING A PRIMARY SURGERY DUE TO INTRA-OPERATIVE COMPLICATIONS. CORIN HAS NOT RECEIVED ANY INFORMATION "REGARING" WHAT THE COMPLICATIONS WERE; HOWEVER, IT HAS BEEN STATED THAT THE CORIN CUP AND STEM WERE NOT AT FAULT FOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33232 TRINITY ACETABULAR HIP SYSTEM LZO CORIN MEDICAL 321.02.348 383080

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R METAFIX STEM - 579.0002, 379729| METAFIX STEM - 579.0002, 379729| METAFIX STEM - 579.0002, 379729