BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    32MM +8 LFIT V40 HEAD

    MDR report key: 6371862 · Received March 2, 2017

    Report

    Report Number
    0002249697-2017-00750
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    February 3, 2017
    Report Date
    May 5, 2017
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    UDI-DI
    07613327013122
    PMA / PMN Number
    K121308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A SIZ/FIT ISSUE INVOLVING A METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION: VISUAL INSPECTION OF THE RETURN PART WAS CARRIED OUT. THE DEVICE WAS VISUALLY UNREMARKABLE. DIMENSIONAL INSPECTION: DIMENSIONAL INSPECTION WAS CARRIED OUT ON THE RETURNED HEAD USING IGS-0030158 VERSION 10 ALL DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. -MEDICAL RECORDS RECEIVED AND EVALUATION: A REVIEW OF A PROVIDED OPERATIVE REPORT BY A CLINICAL PHYSICIAN NOTED: [...] AN ADDITIONAL ADVERSE EFFECT OF MORBID OBESITY IS THE EASY INTERPOSITION OF SOFT TISSUE BETWEEN FEMORAL HEAD AND TRUNNION, COMPLICATING IMPLANTATION. MY SUSPICION IS THAT ONE OF THESE CONSEQUENCES OF THE PATIENT¿S MORBID OBESITY WAS THE CORE OF THE PROBLEM EVEN THOUGH THERE IS NO EXPLICIT PROOF FOR THIS DUE TO LACK OF REPORTED INFORMATION. NO EVIDENCE IS AVAILABLE FOR DEVICE-RELATED MATTERS. THIS IS ALSO SUPPORTED BY THE DIMENSIONAL SPECIFICATION OF THE FEMORAL HEAD UNDER QUESTION WHICH SHOWED EVERYTHING WAS DIMENSIONALLY CORRECT WHILE ALSO THE EXPLANT PHOTOGRAPH DOES NOT DOCUMENT ANY ISSUE WITH THE HEAD. THIS IS FURTHER SUPPORTED BY THE TYPE OF PROBLEM. EVEN IF SUPPOSING THAT THE TAPER WOULD HAVE A WRONG DIAMETER, IT WOULD STILL BE A TAPER THAT IS SMALLER NEAR THE TOP OF THE TRUNNION AND ONLY WOULD RESULT IN A DIFFERENT NECK LENGTH POSITION THAN CALCULATED BUT WOULD NOT RESULT IN INABILITY TO MOUNT THE HEAD. AS SUCH, THE ROOT CAUSE OF THE PROBLEM REPORTED APPEARS TO BE AN ADVERSE MIX OF PROCEDURE-RELATED (LONG FEMORAL HEAD REQUIRED) AND PATIENT-RELATED FACTORS (THE MORBID OBESITY) TO MAKE MOUNTING THE FEMORAL HEAD MORE DIFFICULT THAN USUAL. THE PROBLEM WAS SOLVED BY USING ANOTHER HEAD WHICH MAY SEEM PARADOXICAL BUT PROBABLY SOME ADDITIONAL ¿FIDDLE¿ DURING SURGERY ULTIMATELY RESULTED IN SOLVING THE PROBLEM WITHOUT UNDUE DELAY PROVIDING EITHER THE SPACE REQUIRED FOR IMPLANTATION OF THE HEAD OR THE DISAPPEARANCE OF THE SOFT TISSUE INTERPOSITION. THIS PI CASE IS NOT DEVICE RELATED.[...] DEVICE HISTORY REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW INDICATED THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED, THE METAL HEAD WAS FOUND TO BE DIMENSIONALLY WITHIN SPECIFICATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT HAD A PRIMARY RIGHT HIP DUE TO OSETOARTHRITIS. THE ISSUE WAS THE FEMORAL HEAD DID NOT SIT WELL ON THE TRUNNION. SURGEON REMOVED, CLEANED AND TRIED TWICE. ADDITIONAL DEVICE AVAILABLE. SURGERY COMPLETED SUCCESSFULLY, NO DELAY.

    Description of Event or Problem · 1

    PATIENT HAD A PRIMARY RIGHT HIP DUE TO OSTEOARTHRITIS. THE ISSUE WAS THE FEMORAL HEAD DID NOT SIT WELL ON THE TRUNNION. SURGEON REMOVED, CLEANED AND TRIED TWICE. ADDITIONAL DEVICE AVAILABLE. SURGERY COMPLETED SUCCESSFULLY, NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157467 32MM +8 LFIT V40 HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH STRYKER ORTHOPAEDICS-MAHWAH 55934001 07613327013122

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other