BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN. POLARCUP SHELL CEMENTED

    MDR report key: 14789337 · Received June 23, 2022

    Report

    Report Number
    9613369-2022-00318
    Event Type
    Injury
    Date Received
    June 23, 2022
    Date of Event
    February 1, 2022
    Report Date
    July 29, 2022
    Manufacturer
    SMITH & NEPHEW ORTHOPAEDICS AG
    Product Code
    LPH
    PMA / PMN Number
    K110135
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). MELNIC, C. M., COHEN-LEVY, W. B., LOZANO-CALDERON, S. A., & HENG, M. (2022). TREATMENT OF SEVERE ACETABULAR BONE LOSS USING A TANTALUM ACETABULAR SHELL AND A CEMENTED MONOBLOCK DUAL MOBILITY ACETABULAR CUP. JAAOS-JOURNAL OF THE AMERICAN ACADEMY OF ORTHOPAEDIC SURGEONS, 30(3), E301-E306. 10.5435/JAAOS-D-21-00433.

    Additional Manufacturer Narrative · 0

    H3, H6: THE STUDY OF MELNIC CM ET. AL. [1] REPORTS "TREATMENT OF SEVERE ACETABULAR BONE LOSS USING A TANTALUM ACETABULAR SHELL AND A CEMENTED MONOBLOCK DUAL MOBILITY ACETABULAR CUP". IT WAS REPORTED THAT TWO (2) PATIENTS UNDERWENT THA REVISION SURGERY OF AN UNSPECIFIED PROSTHESIS DUE TO CHRONIC PELVIC DISCONTINUITY. DURING THIS PROCEDURE, A TANTALUM SHELL (ZIMMER) WAS FIXED TO THE ACETABULUM WITH SEVERAL SCREWS AND A DUAL MOBILITY POLARCUP WAS TRAILED AND CEMENTED INTO THE TANTALUM SHELL. AFTER THIS PROCEDURE, THESE TWO (2) PATIENTS EXPERIENCED AN INTRAPROSTHETIC DISLOCATION THAT REQUIRED AN OPEN REDUCTION TO INCREASE THE FEMORAL HEAD OFFSET. THE OUTCOME OF BOTH PATIENTS IS UNKNOWN. AS THIS IS A LITERATURE COMPLAINT, THE DEVICES USED IN TREATMENT, WERE NOT RETURNED FOR INVESTIGATION. THE PART AND THE BATCH NUMBER ARE NOT KNOWN. THEREFORE, IT IS NOT POSSIBLE TO INVESTIGATE WHETHER THE REPORTED DEVICE MET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. AS NO DEVICE WAS RECEIVED FOR INVESTIGATION, A VISUAL INSPECTION COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW WAS PERFORMED. THE OCCURRENCE OF THE REPORTED FAILURE MODE IS WITHIN ITS EXPECTED RISK LEVEL AS PER RISK MANAGEMENT. REVIEW OF PAST CORRECTIVE ACTIONS WAS PERFORMED. NO FURTHER ESCALATION IS REQUIRED. A REVIEW OF THE RISK MANAGEMENT DOCUMENTATION VERIFIES THE FAILURE MODE AND SEVERITY OF THE REPORTED ISSUE. THE IFU (LIT. NO. 12.23 ED 03/21) LISTS SEVERAL POSSIBLE ADVERSE EFFECTS RESULTING FROM A HIP ARTHROPLASTY. A MEDICAL INVESTIGATION WAS CONDUCTED. IT SHOULD BE NOTED THE LITERATURE REVIEW NOTES MIXED-MANUFACTURER COMPONENTS. THE IFU (LIT. NO. 12.23 ED 03/21) WARNS, ¿IMPLANTS AND IMPLANT COMPONENTS OF SMITH & NEPHEW ORTHOPAEDICS AG MUST NOT BE COMBINED WITH OTHER MANUFACTURER IMPLANTS.¿ HOWEVER, WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE IMAGES PROVIDED IN THE ARTICLE HAVE BEEN INTERPRETED WITHIN THE TEXT; THEREFORE, NO FURTHER ANALYSIS OF THE IMAGES IS REQUIRED. THE ROOT CAUSE AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. BASED ON THE CONDUCTED INVESTIGATION THE FAILURE MODE AND THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT CANNOT BE CONFIRMED. DUE TO INSUFFICIENT INFORMATION IT IS NOT POSSIBLE TO SPECULATE ABOUT FACTORS WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO PROBABLE CAUSE CAN BE DETERMINED. TO DATE, NO FURTHER ACTIONS WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS COMPLAINT WILL BE REASSESSED. SMITH AND NEPHEW WILL MONITOR THE DEVICES FOR FURTHER SIMILAR ISSUES.

    Description of Event or Problem · 0

    "IT WAS REPORTED THAT, ON LITERATURE REVIEW "TREATMENT OF SEVERE ACETABULAR BONE LOSS USING A TANTALUM ACETABULAR SHELL AND A CEMENTED MONOBLOCK DUAL MOBILITY ACETABULAR CUP", TWO (2) PATIENTS UNDERWENT THA REVISION SURGERY OF AN UNSPECIFIED PROSTHESIS DUE TO CHRONIC PELVIC DISCONTINUITY. DURING THIS PROCEDURE, A TANTALUM SHELL (ZIMMER) WAS FIXED TO THE ACETABULUM WITH SEVERAL SCREWS AND A DUAL MOBILITY POLARCUP WAS TRAILED AND CEMENTED INTO THE TANTALUM SHELL. AFTER THIS PROCEDURE, THESE TWO (2) PATIENTS EXPERIENCED AN INTRAPROSTHETIC DISLOCATION THAT REQUIRED AN OPEN REDUCTION TO INCREASE THE FEMORAL HEAD OFFSET. THE OUTCOME OF BOTH PATIENTS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307871 UNKN. POLARCUP SHELL CEMENTED PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW ORTHOPAEDICS AG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention