Catalog Number UNK SHOULDER HUMERAL STEM |
Device Problem
Corroded (1131)
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Patient Problem
No Code Available (3191)
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Event Date 06/01/2016 |
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 ¿fretting and corrosion in modular shoulder arthroplasty: a retrieval analysis¿ by johannes a.Eckert, ulrike mueller, sebastian jaeger, benjamin panzram, and j.Philippe kretzer, published in hindawi, june 1, 2016, was reviewed.The purpose was to evaluate tribocorrosion in the retrieval of anatomic shoulder implants upon revision.There were a total of 38 consecutively retrieved anatomic implants for analysis.Out of those 38, four belonged to depuy synthes.It was determined that tribocorrosion was present on 27 of 36 heads (two were excluded from the study).Despite seeing tribocorrosion in the majority of the retrieved implants, only a small subset of 16% showed moderate to severe corrosion for both tapers; most prosthesis featured only mild tribocorrosion.The article did not specify which implants had which degree of tribocorrosion, however did reports it was noted more in mixed metal combinations (ti-cocr).
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Manufacturer Narrative
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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.H10 additional narrative: 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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