BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACETLR CUP HAP 50MM W/ IMPTR

    MDR report key: 12701962 · Received October 26, 2021

    Report

    Report Number
    3005975929-2021-00484
    Event Type
    Injury
    Date Received
    October 26, 2021
    Date of Event
    March 12, 2015
    Report Date
    June 16, 2023
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010502568
    PMA / PMN Number
    P040033
    Removal / Correction Number
    Z-2746-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT A LEFT HIP REVISION SURGERY WAS PERFORMED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. AS NO DEVICE PART AND BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A COMPLAINT HISTORY REVIEW, MANUFACTURING RECORD REVIEW, DEVICE LABELLING / IFU, REVIEW COULD NOT BE PERFORMED. THE DEVICES WOULD HAVE MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. A RISK MANAGEMENT REVIEW WAS PERFORMED. THE ALLEGED FAILURE MODES AND ASSOCIATED RISKS HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. PER THE SURGICAL TECHNIQUE, THE ACETABULAR COMPONENT IS TO BE IMPACTED WITH 15-20 DEGREE OF ANTEVERSION AND 40-45 DEGREE INCLINATION ANGLE. HOWEVER, THE OPERATIVE REPORT¿S INDICATION THAT THE ACETABULAR COMPONENT WAS ¿VERY ANTEVERTED¿. IT IS UNKNOWN IF THIS POSITION OF THE ACETABULAR COMPONENT WAS A MIGRATION SINCE IMPLANTATION AND IF LED TO ACCELERATED WEAR AND THE REPORTED ELEVATED COBALT AND CHROMIUM LEVELS, AND INTRAOPERATIVE FINDINGS OF METAL STAINING AND THICKENING OF THE SOFT TISSUE. ALTHOUGH IT WAS REPORTED THE PATIENT HAD ELEVATED COBALT AND CHROMIUM LEVELS, NEITHER THE LEVELS NOR THE LABORATORY REPORTS WERE PROVIDED FOR REVIEW. WITHOUT THE SUPPORTING LABORATORY/PATHOLOGY RESULTS, IMAGING, AND/OR THE ANALYSIS OF THE EXPLANTED COMPONENTS, THE ROOT CAUSE OF THE REPORT CLINICAL REACTIONS CANNOT BE CONFIRMED. IT CANNOT BE CONCLUDED THAT THE REPORTED CLINICAL REACTIONS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT OR IMPLANT FAILURE. THE PATIENT IMPACT BEYOND REVISION AND EXPECTED TRANSIENT POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT IS WARRANTED AT THIS TIME. WITHOUT THE RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE REPORTED COMPLAINT, OR THE DETAILS SUPPLIED IN THIS COMPLAINT. THE INVESTIGATION REMAINS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. ADDITIONALLY, SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT CANNOT BE PROVIDED DUE TO THE INSUFFICIENT INFORMATION. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE AND PREVENTATIVE ACTIONS IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H010: ADDITIONAL INFORMATION ADDED IN B6,B7, D1, D2, D4 AND G4. H11: CORRECTED DATA IN B3.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL INFORMATION IN D9. FDA RECALL - Z-2746-2015 FOR 74121142 RESURFACING FEMORAL HEAD 42MM LOT# 080860; H3, H6. IT WAS REPORTED THAT A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO ELEVATED LEVELS OF COBALT AND CHROMIUM, METAL STAINING AND THICKENING OF THE SOFT TISSUE. AS OF TODAY, THE IMPLANTED DEVICES, ALL OF WHICH WERE USED IN TREATMENT HAVE NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE HISTORICAL COMPLAINTS DATA FOR THE DEVICES CONCERNED WAS PERFORMED USING BATCH NUMBERS, PART NUMBERS AND THE REPORTED FAILURE MODES TO EVALUATE PATTERNS OF REPEATED FAILURES OR DEFECTS. SIMILAR COMPLAINTS HAVE BEEN IDENTIFIED FOR THE HEAD AND THE CUP. THIS WILL CONTINUE TO BE MONITORED VIA ROUTINE TRENDING, HOWEVER IT SHOULD BE NOTED THAT THIS DEVICE IS NO LONGER SOLD. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. THE REVIEW OF THE PRODUCT IFU FOUND ADEQUATE WARNINGS AND PRECAUTIONS IN RELATION TO THE ALLEGED FAILURE MODES. A RISK MANAGEMENT REVIEW WAS PERFORMED. THE ALLEGED FAILURE MODES AND ASSOCIATED RISKS HAVE BEEN ANTICIPATED WITHIN THE RISK FILE AND THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF HISTORIC ESCALATION ACTIONS RELATED TO THE PRODUCTS AND SIMILAR COMPLAINT EVENTS WAS PERFORMED. FOLLOWING THE REVIEW, PRIOR APPLICABLE ESCALATION ACTIONS WERE IDENTIFIED AND CONFIRMED TO REDUCE ASSOCIATED RISKS AS FAR AS POSSIBLE. NO FURTHER ESCALATION ACTIONS ARE REQUIRED. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. PER THE SURGICAL TECHNIQUE, THE ACETABULAR COMPONENT IS TO BE IMPACTED WITH 15-20 DEGREE OF ANTEVERSION AND 40-45 DEGREE INCLINATION ANGLE. HOWEVER, THE IMPLANTATION OPERATIVE REPORT INDICATED THE ACETABULAR COMPONENT WAS IMPACTED AT APPROXIMATELY 25 DEGREES OF ANTEVERSION AND THE REVISION OPERATIVE REPORT INDICATED THAT THE ACETABULAR COMPONENT WAS ¿VERY ANTEVERTED¿. IT IS UNKNOWN IF THIS POSITION OF THE ACETABULAR COMPONENT, AS WELL AS THE PATIENT¿S AGGRESSIVE WORKOUTS, LED TO ACCELERATED WEAR AND THE REPORTED ELEVATED COBALT AND CHROMIUM LEVELS, AND INTRAOPERATIVE FINDINGS OF METAL STAINING AND THICKENING OF THE SOFT TISSUE. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED ELEVATED METAL ION LEVELS AND INTRAOPERATIVE FINDINGS OF METAL STAINING, SOFT TISSUE THICKENING SUGGESTIVE OF SOME REACTION TO DEBRIS CANNOT BE CONFIRMED. IT CANNOT BE CONCLUDED THAT THE REPORTED CLINICAL REACTIONS WERE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT OR IMPLANT FAILURE. THE PATIENT IMPACT BEYOND REVISION AND EXPECTED TRANSIENT POST-OP CONVALESCENCE PERIOD CANNOT BE DETERMINED. BASED ON THE INFORMATION PROVIDED, FURTHER INVESTIGATION OF THE REPORTED COMPLAINT CANNOT BE CARRIED OUT AND REMAINS INCONCLUSIVE. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT ARE EXCESSIVE PHYSICAL ACTIVITY LEVELS, UNREASONABLE STRESS ON REPLACEMENT SYSTEM, EXCESSIVE PATIENT WEIGHT, TRAUMA TO THE JOINT REPLACEMENT, LOOSENING OF COMPONENTS MAY INCREASE PRODUCTION OF WEAR PARTICLES AND ACCELERATE DAMAGE TO THE BONE . SHOULD THE DEVICES OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE AND PREVENTATIVE ACTIONS IS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT, AFTER A PRIMARY LEFT BHR RESURFACING CONSTRUCT HAD BEEN IMPLANTED ON THE PLAINTIFF¿S HIP ON (B)(6) 2008, THE PLAINTIFF EXPERIENCED ELEVATED LEVELS OF COBALT AND CHROMIUM, METAL STAINING AND THICKENING OF THE SOFT TISSUE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. DURING THE SURGERY SOME METAL STAINING OF THE TISSUE AND SOME THICKENING OF THE SOFT TISSUE SUGGESTIVE OF SOME REACTION TO DEBRIS FROM THE METAL BEARING SURFACE WAS FOUND. THE PLAINTIFF¿S OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1598843 ACETLR CUP HAP 50MM W/ IMPTR PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD 076505 03596010502568

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R 74121142 / LOT # 080860