BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCR 12/14 FEM HEAD 32 + 4

    MDR report key: 14520062 · Received May 26, 2022

    Report

    Report Number
    1020279-2022-02626
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    February 18, 2022
    Report Date
    June 20, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LPH
    UDI-DI
    03596010194190
    PMA / PMN Number
    K963509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4). MASTEL, M., BOISVERT, A., MOORE, R., SUTHERLAND, F., & POWELL, J. (2022). METALLOSIS FOLLOWING HIP ARTHROPLASTY: TWO CASE REPORTS. JOURNAL OF MEDICAL CASE REPORTS, 16(1), 1-9. DOI: HTTPS://DOI.ORG/10.1186/S13256-022-03336-4.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION BUT THE PICTURES WERE REVIEWED, AND THE TRUNNION WEAR WAS CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, PER THE COMPLAINT DETAILS, NO FURTHER INFORMATION IS AVAILABLE. CONSEQUENTLY, 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. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY REVEALED SIMILAR EVENTS FOR THE LISTED DEVICE OVER THE PREVIOUS 12 MONTHS, BUT NO SIMILAR EVENTS FOR THE BATCH BASED ON THE HISTORICAL DATA, THIS FAILURE MODE WILL BE MONITORED FOR FUTURE COMPLAINTS FOR ANY NECESSARY CORRECTIVE ACTIONS. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR TOTAL HIP SYSTEMS REVEALED THAT DISLOCATIONS, SUBLUXATION, DECREASED RANGE OF MOTION, OR LENGTHENING OR SHORTENING OF THE FEMUR CAN OCCUR HAS BEEN IDENTIFIED AS A POTENTIAL COMPLICATIONS ASSOCIATED WITH TOTAL HIP ARTHROPLASTY SURGERY, PRIMARY OR REVISION. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE TRAUMATIC INJURY, PATIENT ANATOMY, FRICTION, JOINT TIGHTNESS, EXCESSIVE FORCES, ABNORMAL LOADING, DAMAGED PRODUCT OR WEAR. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED INCIDENT COULD BE CORROBORATED AS IT WAS REQUIRED A REVISION SURGERY TO TREAT THIS EVENT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE LITERATURE REVIEW "METALLOSIS AFTER HIP ARTHROPLASTY: TWO CASE REPORTS", 1 PATIENT SUFFERED 2 DISLOCATIONS (UNKNOWN IN WHICH IMPLANTS) THE FIRST 8 YEARS LATER AND THE SECOND 9 YEARS AND 7 MONTHS LATER OF THE RIGHT INITIAL R3-THA SURGERY. AT THE TIME OF THE SECOND DISLOCATION, RADIOGRAPHS SUGGESTED RADIOLUCENCY IN THE GREATER TROCHANTER AND SOFT TISSUE DARKENING AND MINERALIZATION ANTERIOR TO THE JOINT. MRI IMAGING REVEALED COMPLEX MULTILOCULATED FLUID COLLECTIONS SUGGESTING AN EXTENSIVE PSEUDOTUMOR. SIX WEEKS AFTER CONFIRMATION OF PSEUDOTUMOR, THE PATIENT UNDERWENT COMPLETE EXCISION OF THE PSEUDOTUMOR FOLLOWED BY REVISION OF RIGHT R3-THA AND RECONSTRUCTION OF THE ABDUCTOR MECHANISM. DURING REVISION SURGERY, TRUNNION WEAR WITH BLACK DEPOSITS ON THE FEMORAL NECK WAS OBSERVED. AT 6 WEEKS FOLLOW-UP PATIENT WAS RECOVERING WELL. THERE'S NO MORE AVAILABLE INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753285 COCR 12/14 FEM HEAD 32 + 4 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED LPH SMITH & NEPHEW, INC. 71303204 10EM11629 03596010194190

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other| H| R UNKN SYNERGY HIP STEM