Catalog Number UNK SHOULDER METAGLENE |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 02/06/2013 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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"the literature article entitled ¿short and midterm results of reverse shoulder arthroplasty according to the preoperative etiology¿ by mathias wellmann; melena struck; marc frederic pastor; andre gettmann; henning windhagen; and tomas smith, published online in the arch orthopaedic trauma surgery on february 6, 2013 was reviewed.The purpose of the article was to review reverse shoulder arthroplasty to see if the preoperative etiology influences clinical results after rsa.The article reviewed 76 reverse shoulder arthroplasties for cuff tear arthropathy, fracture sequelae and revision arthroplasty.The follow-up consisted of 71 patients and the mean follow-up period was 23 months.All patients were evaluated postoperatively using the constant score and the simple shoulder test.The patients either had the delta xtend (51) or the delta 3.2 (25), depuy, implanted.71 patients were clinically investigated for a follow-up examination.There were postoperative complications in 19 patients.Scapular notching was also noted in 33 patients." (b)(6) female; loosening of glenoidal components 32 months after surgery due to scapular notching and required one stage revision with replacement of metaglene.
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Manufacturer Narrative
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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 code(s) 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.Corrective action was not indicated.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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Search Alerts/Recalls
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