BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL HEAD - 24MM

    MDR report key: 5463159 · Received February 26, 2016

    Report

    Report Number
    3004608878-2016-00034
    Event Type
    Injury
    Date Received
    February 26, 2016
    Date of Event
    April 22, 2014
    Report Date
    February 1, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    KWI
    PMA / PMN Number
    K032806
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF THE LEGAL DOCUMENT RECEIVED ON JUNE 13, 2016: ON (B)(6) 2014 A (B)(6) MALE HAD AN ACCIDENT WHILE RIDING HIS SKATEBOARD. HE WAS TAKEN TO EMERGENCY ROOM AND X-RAYS CONFIRMED A DIAGNOSIS OF A COMPLEX COMMINUTED FRACTURE DISLOCATION OF THE PROXIMAL FOREARM WITH A COMMINUTED FRACTURE OF THE PROXIMAL ULNAR DIAPHYSIS WITH APEX DORSAL ANGULATION AND DISLOCATION OF THE RADIAL HEAD WITH IMPACTION FRACTURE. ON (B)(6) 2014, WAS PERFORMED A RADIAL HEAD REPLACEMENT AS WELL AS AN OPEN REDUCTION AND INTERNAL FIXATION OF THE ULNA USING CANCELLOUS BONE CHIPS AND DBX BONE GRAFT. FOLLOWING SURGERY AND OCCUPATIONAL THERAPY, THE PATIENT WAS DISCHARGED WITH INSTRUCTIONS ON AT-HOME SPLINT MANAGEMENT. ON (B)(6) 2014 ON HIS POST-SURGERY FOLLOW-UP, THE SPLINT WAS REMOVED AND HE WAS FOUND TO BE IN IMPROVED AND STABLE CONDITION IN REGARDS TO HIS ELBOW. ON (B)(6) 2014, THREE MONTHS AFTER THE IMPLANTATION, THE PATIENT WAS GETTING OUT OF HIS BED IN THE MORNING, SUPPORTING HIMSELF WITH BOTH ARMS, WHEN HE FELT HIS RIGHT ELBOW GIVE, AND IMMEDIATELY EXPERIENCED PAIN, SWELLING, AND LIMITED MOBILITY. AN X-RAY CONFIRMED A SUBLUXATION OF THE DISTAL RADIAL COMPONENT 10MM LATERALLY. THIS SUBLUXATION FORCED GREAT STRESS ON THE OLECRANON PLATE IMPLANTED ON THE ULNA, CAUSING IT TO FRACTURE. THE PATIENT PLANS TO HAVE THE REVISION SURGERY DONE AT THE END OF SUMMER 2016.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON JULY 20, 2016. THE INVESTIGATION INCLUDED: METHODS: RADIOGRAPHS EVALUATION, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: BASED ON THE EXAMINATION OF THE RADIOGRAPHS PROVIDED, INTEGRA IS ABLE TO CONFIRM THE REPORTED NON-CONFORMANCE. THE 24 MM KATALYST RADIAL HEAD/ POLY ASSEMBLY (P/N 22-1424) DETACHED FROM THE 6.5 MM RADIAL HEAD STEM ASSEMBLY (P/N 22-1665). THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AND THEREFORE WE ARE UNABLE TO DETERMINE IF THE RADIAL HEAD / POLY ASSEMBLY DETACHED FROM THE RADIAL HEAD STEM ASSEMBLY DUE TO MECHANICAL FAILURE, SURGICAL TECHNIQUE, THE PATIENT¿S PHYSICAL CONDITION OR A COMBINATION OF FACTORS. SINCE NO ONE AT ILS (B)(4) IS CLINICALLY QUALIFIED TO INTERPRET RADIOGRAPHS, NO FURTHER CONCLUSIONS REGARDING THE CAUSE OF THE ALLEGED DEVICE FAILURES AND NON-FUSION OF THE ULNA CAN BE MADE. DHR REVIEW; THE LOT NUMBERS OF THE TWO PORTIONS OF THE FINAL IMPLANT (P/N 221424 AND P/N 221665) WERE NOT PROVIDED. COMPLAINTS HISTORY; A QUERY FOUND SIX ADDITIONAL COMPLAINTS ASSOCIATED WITH THE REPORTED FAILURE OF AN IMPLANTED KATALYST RADIAL HEAD/POLY ASSEMBLY. THE QUERY WAS BASED ON SEARCHING FOR ¿KATALYST¿ AND THE THREE RADIAL HEAD/POLY ASSEMBLY IMPLANT PART NUMBERS, 221418, 221421 AND 221424. THE QUERY WAS LIMITED TO THE TIME FRAME OF JANUARY 1, 2010 ¿ DECEMBER 31, 2015. THE TREND ANALYSIS FAILURE RATE WAS PERFORMED BY DETERMINING THE NUMBER OF REPORTED NON-CONFORMANCES FOR THE PARTICULAR IMPLANT. A FAILURE RATE PERCENTAGE WAS DETERMINED BY CALCULATING THE NON-CONFORMANCE RATE AS A FUNCTION OF THE NUMBER OF OPPORTUNITIES. A REVIEW OF DOMESTIC AND INTERNATIONAL SALES INFORMATION DETERMINED THAT APPROXIMATELY (B)(4) KATALYST RADIAL HEAD/POLY ASSEMBLIES (P/N 22-14XX) WERE SOLD DURING THE TIME FRAME OF JANUARY 2010 ¿ DECEMBER 31, 2015. INCLUDING THIS COMPLAINT, THE SEVEN REPORTED COMPLAINTS REPRESENT A FAILURE RATE OF (B)(4). CONCLUSION: THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION AND THEREFORE INTEGRA IS UNABLE TO DETERMINE IF THE RADIAL HEAD / POLY ASSEMBLY DETACHED FROM THE RADIAL HEAD STEM ASSEMBLY DUE TO MECHANICAL FAILURE, SURGICAL TECHNIQUE, THE PATIENT¿S PHYSICAL CONDITION OR A COMBINATION OF FACTORS. SINCE NO ONE AT ILS (B)(4) IS CLINICALLY QUALIFIED TO INTERPRET RADIOGRAPHS, NO FURTHER CONCLUSIONS REGARDING THE CAUSE OF THE ALLEGED DEVICE FAILURES AND NON-FUSION OF THE ULNA CAN BE MADE.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    OTHER MFG REPORT # 3004608878-2016-00035. THIS REPORT IS ABOUT A (B)(6) MALE THAT ON (B)(6) 2014 UNDERWENT A RIGHT ELBOW PROSTHESIS IMPLANTATION. SHORTLY AFTER THAT, HE STARTED EXPERIENCING PAIN AND LIMITED MOBILITY AROUND HIS ELBOW, NECESSITATING A REVISION SURGERY. SUBSEQUENT X-RAYS CONDUCTED ON (B)(6) 2014 CONFIRMED AN UNUNITED FRACTURE, PROXIMAL THIRD OF RIGHT ULNA, WITH THE POSTERIOR COMPRESSION PLATE FRACTURED THROUGH ITS MIDDLE THIRD AND WITH LATERAL DISPLACEMENT OF THE UNUNITED DISTAL ULNAR FRAGMENT. PRIOR TOTAL ARTHROPLASTY, RADIOHUMERAL JOINT, WITH LATERAL SUBLUXATION OF THE DISTAL RADIAL COMPONENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121354 RADIAL HEAD - 24MM KATALYST BIPOLAR RADIAL HEAD SYSTEM KWI INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other 13_5 X 16MM NON-LOCK HEX SCREW-NOT INTEGRA DEVICE