BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRMINGHAM HIP RESURFACING

    MDR report key: 7836356 · Received August 31, 2018

    Report

    Report Number
    3005975929-2018-00293
    Event Type
    Injury
    Date Received
    August 31, 2018
    Date of Event
    August 12, 2014
    Report Date
    April 2, 2019
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS LTD
    Product Code
    NXT
    UDI-DI
    03596010502575
    PMA / PMN Number
    08/10/2018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO METALLOSIS, SOFT TISSUE REACTION, SEVERE AND INCREASING HIP PAIN AND SWELLING WITH SEVERE METAL TO METAL REACTION, LIMITED RANGE OF MOTION IN THE HIP AND LEG, PAIN, STIFFNESS, LIMITATION ON ACTIVITIES OF DAILY LIVING, AND DIFFICULTY WITH MOBILITY. DURING THE REVISION THE BHR HEAD AND BHR CUP WERE REMOVED. AS OF TODAY, DEVICE RETURN AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FOR THIS COMPLAINT BUT HAS NOT BECOME AVAILABLE. IN THE ABSENCE OF THE ACTUAL DEVICES, THE PRODUCTION RECORDS WERE REVIEWED FOR THE DEVICES REPORTEDLY INVOLVED IN THIS INCIDENT. ALL THE RELEASED DEVICES INVOLVED MET MANUFACTURING SPECIFICATIONS AT THE TIME OF PRODUCTION. THE AVAILABLE MEDICAL DOCUMENTS WERE REVIEWED. THE PRIMARY OPERATIVE REPORT INDICATED THAT THE BHR WAS IMPLANTED DUE TO DEGENERATIVE JOINT DISEASE OF THE RIGHT HIP. THE REVISION SURGICAL REPORT INDICATES THAT FOLLOWING THE PRIMARY RESURFACING, THE PATIENT HAD PERSISTENT PAIN AND TWO ARTHROSCOPIC PROCEDURES PRIOR TO THE REVISION; ALTHOUGH THEY WERE PERFORMED AT ANOTHER FACILITY. THE REPORT ALSO INDICATED THAT ¿THE PATIENT WAS PRESUMED TO HAVE A WELL FIXED HIP IMPLANT WITHOUT INFECTION, BUT DEMONSTRATED OSTEOLYSIS PRESUMED TO BE A BIOLOGIC REACTION TO THE METAL. THERE WAS NO VISIBLE BUT METALLIC TISSUE STAINING AND THE SYNOVIAL FLUID WAS CLEAR YELLOW¿. A THICK PSEUDO CAPSULE AND ASSOCIATED SYNOVITIS THAT EXTENDED INTO THE PSOAS BURSA, AND THE GRANULOMA WAS REMOVED. HIP ASPIRATION REVEALED A LOW NUMBER OF NEUTROPHILS AND A LEFT SHIFT OF ONLY 53%. SERUM CHROMIUM MEASURED 2.8 MCG/L AND COBALT 1.7 MCG/L, HOWEVER NO LAB REPORTS HAVE BEEN PROVIDED AND THE EXPLANTED DEVICE WAS NOT RETURNED FOR ANALYSIS. THE CLINICAL INFORMATION PROVIDED IS CONSISTENT WITH REACTIONS FROM METAL DEBRIS; HOWEVER, THE SOURCE CANNOT BE CONFIRMED. AS NO OTHER INFORMATION WAS PROVIDED, THE RELEVANCE REGARDING THE HIGH BLOOD METAL IONS CANNOT BE FURTHER INVESTIGATED. IT CANNOT BE CONCLUDED WHETHER THE REPORTED CLINICAL REACTIONS ARE ASSOCIATED WITH A MAL-PERFORMANCE OF THE IMPLANT. WITHOUT RETURN OF THE ACTUAL DEVICES OR FURTHER INFORMATION WE CANNOT FURTHER INVESTIGATE OR CONFIRM THE DETAILS SUPPLIED IN THIS COMPLAINT, AND OUR INVESTIGATION REMAINS INCONCLUSIVE. 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 · 1

    IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED. METALLOSIS, SOFT TISSUE REACTION, SEVERE AND INCREASING HIP PAIN, SWELLING WITH METAL TO METAL REACTION, LIMITED RANGE OF MOTION IN HIP AND LEG, PAIN, STIFFNESS, LIMITATION ON ACTIVITIES OF DAILY LIVING, AND DIFFICULTY WITH MOBILITY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679498 BIRMINGHAM HIP RESURFACING BHR ACETABULAR CUP NXT SMITH & NEPHEW ORTHOPAEDICS LTD 083340 03596010502575

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R FEMORAL HEAD, # 74121146, LOT # 080076| FEMORAL HEAD, # 74121146, LOT # 080076