Catalog Number UNK-EXTREM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Osteolysis (2377)
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Event Date 10/15/2015 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Follow-up with the complainant has been conducted for the catalog number and lot number and this information is unavailable.
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Event Description
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Patient was revised to address pain, osteolysis and talar loosening, non-cemented.
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Manufacturer Narrative
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Examination of the returned sp2 universal handle confirmed fracture at the square-to-circular (.183 dimension) cross-section changes of the distal end of the external rod sub-component.The overall condition of the instrument indicates heavy usage and impactions over time.A design modification to change to the undercut details of the square-to-circular (.183 dimension) cross-section was implemented in (b)(4) 2012 via eco400749 (rev.F) to reduce incidence of instrument failure.A search of the complaint database against product code 966520 did not find any reports of fracture manufactured after the december 2012 design modification.Although the submitted sp2 universal handle was manufactured prior to the design modification, it has been subjected to heavy usage and the root cause is attributed to normal use and servicing.The submitted sp2 universal handle was manufactured prior to the design modification in december of 2012 and the need for corrective action is not indicated.Monitor for reported events of fracture for sp2 universal handles manufactured after december 2012.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Search Alerts/Recalls
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