The literature article entitled, "cementless versus cemented glenoid components in conventional total shoulder joint arthroplasty: analysis from the australian orthopaedic association national joint replacement registry" written by richard s.Page, mbbs, bmedsci, fracs, faortha, vishal pai, mbchb, kevin eng, mbbs (hons), fracs, faortha, gregory bain, mbbs, fracs, faortha, phd, stepeh graves, mbbs, fracs, faortha, dphil, and michelle lorimer, bsc (hons) published by journal of shoulder and elbow surgery 2018 was reviewed.The article's purpose was to compare the revision rates of cemented and cementless design glenoid components used in conventional total shoulder arthroplasty (tsa) performed for the diagnosis of osteoarthritis.Data was compiled from the australian orthopaedic association national joint replacement between april 16, 2004 and december 31, 2016 consisting of 10,805 primary conventional tsas.The article notes that depuy products along with non-depuy products are listed under the cemented: all polyethylene glenoid category provided in table 1.The reasons for revisions for the cemented glenoids are listed in table ii but the article does not clarify which specific revision reasons are associated with specifically depuy products.Cement manufacturer is not identified.Depuy product: global/global advantage all poly cemented glenoid, humeral stem, humeral head adverse event(s): revisions for rotator cuff insufficiency, instability and or dislocation, loosening (no further information provided), infection, implant breakage of glenoid, fracture (anatomical location not provided), pain, incorrect sizing (no further information provided to clarify meaning or application of coding), arthrofibrosis, malposition (no further information provided), lysis (no further information provided), glenoid erosion (reference to bone structure and not implant), implant breakage of humeral component.
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.
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