Catalog Number UNK SHOULDER LOCKING SCREW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Neurological Deficit/Dysfunction (1982); No Code Available (3191)
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Event Type
Injury
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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.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.8 patients involved.
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Event Description
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Update 14-jan-2018: "reverse shoulder arthroplasty for the treatment of three- and four-part fractures of the proximal humerus in the elderly" was read for mdr reportability.After review of the article for mdr reportability, the article indicates a delta reverse shoulder was implanted in 43 patients between january 2000 to january 2005.No patient identifies were provided for the 43 patients.Of the 43 patients the following patient harms and product deficiencies were noted: five patients experienced neurological complications which mostly resolved; three patients experienced reflex sympathetic dystrophy which resolved.
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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.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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