BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3832473 · Received May 27, 2014

    Report

    Report Number
    0002249697-2014-01951
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A LOOSE FEMORAL STEM INVOLVING AN UNKNOWN ACETABULAR COMPONENT WAS REPORTED. DURING THE INVESTIGATION, IT WAS IDENTIFIED THE POSITIONING OF THE ACETABULAR SHELL MAY HAVE CONTRIBUTED TO THE EVENT. THE IDENTIFIED ACETABULAR COMPONENT MALPOSITION WAS CONFIRMED. REVIEW OF THE PROVIDED RECORDS BY A CONSULTING CLINICIAN NOTED: "- STEM SIZE APPEARS A BIT ON THE SMALL SIDE WHEN COMPARED TO THE SPACE AVAILABLE WITHIN THE FEMORAL CANAL, BOTH ON THE AP VIEW AND THE LATERAL VIEW. BONE QUALITY APPEARS GOOD BUT RELATIVE UNDERSIZING CONTRIBUTES TO EXCESSIVE MICRO-MOTION AROUND THE STEM DURING WALKING. TOO MUCH MICRO-MOTION HAS SEVERE ADVERSE EFFECT ON BONE INGROWTH EARLY AFTER SURGERY [...] -NEVERTHELESS, BASED ON THE COMBINED FACT OF SUBOPTIMAL CUP POSITION LEADING TO HIGH PROBABILITY OF IMPINGEMENT BETWEEN STEM NECK AND CUP RIM PLUS A SOMEWHAT UNDERSIZED FEMORAL COMPONENT, THERE MUST HAVE BEEN AN OVERLOAD CONDITION IN THE FEMORAL IMPLANTBONE INTERFACE THAT HAS HAD AN ADVERSE EFFECT ON ADEQUATE OSSEO-INTEGRATION OF THE STEM LEADING TO EARLY LOOSENING AND REVISION WITHIN 15-MONTHS POST PRIMARY ARTHROPLASTY. BECAUSE BOTH OPTIMAL COMPONENT SIZE AND POSITION ARE THE RESPONSIBILITY OF THE SURGEON, THESE FACTORS ARE PROCEDURE-RELATED [...] -AS SUCH, BASED ON CLINICAL AND RADIOLOGICAL FINDINGS, THE MOST PROBABLE FAILURE SCENARIO FOR THIS CASE HAS BEEN AN ADVERSE MIX OF PROCEDURE-RELATED FACTORS REGARDING FEMORAL COMPONENT SIZE AND CUP POSITION THAT EITHER ALONE OR IN CONCERT HAVE EFFECTED AN OVERLOAD CONDITION IN THE ARTHROPLASTY BEARING SECTION WITH ADVERSE EFFECTS ON STEM OSSEO-INTEGRATION WITH THE CUP RELATIVELY BEING PROTECTED BY ADDITIONAL CANCELLOUS SCREW FIXATION. NO EVIDENCE FOR THE PRESENCE OF EITHER PATIENT-RELATED OR DEVICE-RELATED FACTORS." THE REVIEW CONCLUDED: "BASED ON CLINICAL AND RADIOLOGICAL FINDINGS, THE MOST PROBABLE FAILURE SCENARIO FOR THIS CASE HAS BEEN AN ADVERSE MIX OF PROCEDURE-RELATED FACTORS REGARDING FEMORAL COMPONENT SIZE AND CUP POSITION THAT EITHER ALONE OR IN CONCERT HAVE EFFECTED AN OVERLOAD CONDITION IN THE ARTHROPLASTY BEARING SECTION WITH ADVERSE EFFECTS ON STEM OSSEO-INTEGRATION WITH THE CUP RELATIVELY BEING PROTECTED BY ADDITIONAL CANCELLOUS SCREW FIXATION. NO EVIDENCE FOR THE PRESENCE OF EITHER PATIENT-RELATED OR DEVICE-RELATED FACTORS." CONCLUSION: REVIEW OF THE PROVIDED X-RAY IMAGES CONFIRMED THE ACETABULAR CUP WAS POSITIONED IN A LESS THAN OPTIMAL ANGLE OF INCLINATION. THE X-RAY REVIEW FOUND NO EVIDENCE OF LOOSENING OR MOVEMENT OF THE CUP POST-IMPLANTATION, THIS IS SUPPORTED BY THE REVISION OPERATIVE REPORT WHICH NOTED THE CUP TO BE WELL FIXED AT THE TIME OF REVISION. THE ROOT CAUSE OF THE MALPOSITION IS DETERMINED TO BE RELATED TO USER FACTORS DURING INITIAL IMPLANTATION. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    REVISION SURGERY REQUIRED AS A SECURFIT STEM IMPLANTED IN (B)(6) 2012 WAS OBVIOUSLY LOOSE ON X-RAY AND PATIENT IN SEVERE DISCOMFORT. STEM WAS REMOVED AND A PRIMARY STEM IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311303 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention