BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE)

    MDR report key: 14431063 · Received May 18, 2022

    Report

    Report Number
    3005975929-2022-00259
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    March 2, 2021
    Report Date
    July 15, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE-(B)(4). ARTICLE CITE: DAGAN, M., RUSS, M. K., & HARE, J. L. (2021). CASE OF MISTAKEN IDENTITY: COBALT CARDIOMYOPATHY VERSUS AMYLOIDOSIS ON CARDIAC MRI. CIRCULATION. CARDIOVASCULAR IMAGING, 14(3), E011561. HTTPS://DOI.ORG/10.1161/CIRCIMAGING.120.011561.

    Additional Manufacturer Narrative · 0

    H3, H6: IT WAS REPORTED THAT ON LITERATURE REVIEW "CASE OF MISTAKEN IDENTITY: COBALT CARDIOMYOPATHY VERSUS AMYLOIDOSIS ON CARDIAC MRI", ONE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON 2017 DUE TO PAIN, SWELLING, METALLOSIS, PSEUDOTUMOR FORMATION AND EXTREME ACETABULAR BONE LOSS. THE PATIENT WAS DIAGNOSED WITH COBALT TOXICITY, WHICH ACCOUNTED FOR BOTH PERIPHERAL NEUROPATHY AND THE PROGRESSIVE CARDIOMYOPATHY. SIX WEEKS AFTER REVISION, THE CARDIAC FUNCTION HAD SIGNIFICANTLY IMPROVED, AND SIX MONTHS AFTER REVISION, IT DEMONSTRATED FURTHER IMPROVEMENT. NO FURTHER INFORMATION IS AVAILABLE AND THE DEVICES, USED IN TREATMENT, WERE NOT AVAILABLE FOR ANALYSIS. AS NO DEVICE PART AND BATCH NUMBERS WERE PROVIDED FOR INVESTIGATION, A COMPLAINT HISTORY REVIEW, MANUFACTURING RECORD REVIEW, DEVICE LABELLING INSTRUCTIONS FOR USE REVIEW COULD NOT BE PERFORMED. IF MORE INFORMATION IS RECEIVED, THIS INVESTIGATION WILL BE REOPENED. 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. A RISK MANAGEMENT REVIEW WAS PERFORMED FOR THE ACETABULAR CUP AND FEMORAL HEAD. 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. THE REPORTED PAIN, ELEVATED COBALT, AND PSEUDOTUMOR MAY BE CONSISTENT WITH THE INTRAOPERATIVE FINDINGS OF METALLOSIS AND ACETABULAR BONE LOSS; HOWEVER, THE CLINICAL ROOT CAUSE OF THE METALLOSIS AND ACETABULAR BONE LOSS CANNOT BE CONFIRMED. THE COBALT LEVEL OF 1369 NMOL/L (CONVERTED TO 80.8 ¿G/L), PERIPHERAL NEUROPATHY AND PROGRESSIVE CARDIOMYOPATHY MAY BE CONSISTENT WITH THE REPORTED COBALT TOXICITY; HOWEVER, THE CLINICAL ROOT CAUSE OF THE COBALT TOXICITY CANNOT BE CONFIRMED. ALTHOUGH THE PATIENT IMPACT BEYOND THE REPORTED EVENTS/ CLINICAL REACTIONS CANNOT BE DETERMINED, IT IS NOTED 6 MONTHS POST REVISION LVEF OF 52% AND NORMAL LEFT VENTRICULAR VOLUME AND MASS, HOWEVER, LGE PERSISTED, AND COBALT 0 NMOL/L. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE THE DETAILS SUPPLIED IN THIS COMPLAINT, OUR INVESTIGATION REMAINS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. BASED ON THE LIMITED INFORMATION PROVIDED WE ARE UNABLE TO SPECULATE ON SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED FAULT. IF THE PRODUCTS OR ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, THIS CASE WILL BE REOPENED. NO PREVENTATIVE OR CORRECTIVE ACTION HAS BEEN INITIATED AS A RESULT OF THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON LITERATURE REVIEW "CASE OF MISTAKEN IDENTITY: COBALT CARDIOMYOPATHY VERSUS AMYLOIDOSIS ON CARDIAC MRI", ONE PATIENT UNDERWENT A REVISION SURGERY OF THE RIGHT HIP ON 2017 DUE TO PAIN, SWELLING, METALLOSIS, PSEUDOTUMOR FORMATION AND EXTREME ACETABULAR BONE LOSS. THE PATIENT WAS DIAGNOSED WITH COBALT TOXICITY, WHICH ACCOUNTED FOR BOTH PERIPHERAL NEUROPATHY AND THE PROGRESSIVE CARDIOMYOPATHY. 6 WEEKS AFTER REVISION, THE CARDIAC FUNCTION HAD SIGNIFICANTLY IMPROVED, AND 6 MONTHS AFTER REVISION, IT DEMONSTRATED FURTHER IMPROVEMENT. THE PRIMARY RIGHT BHR SURGERY WAS PERFORMED IN 2003. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501940 UNKN BIRMINGHAM HIP RESURFACING (BHR) CUP (UNKN TYPE) PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING NXT SMITH & NEPHEW ORTHOPAEDICS LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| H