Catalog Number 129435120 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); No Code Available (3191)
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Event Date 08/26/2011 |
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.Concomitant med products: mbt revision cem tib tray sz 2; srom nrh fem w/pin xsmrt 66x58; lps univ tib hin ins xsm 12mm; unknown knee patella component; depuy cmw 2 20g; universal fem slv ful por 31mm; universal stem 75x14mm fluted; srom nrh dist aug xs/s/md 5mm; srom nrh dist aug xs/s/md 10mm; universal stem 75x10mm fluted; mbt tray sleeve por m/l 29mm.
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Event Description
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(b)(6).Dots.Clinical adverse event received for above the knee amputation related to wound dehiscence.Event is serious and is considered severe.Event is possibly related to device and definitely related to procedure.Doe: (b)(6) 2011; doi: (b)(6) 2011; date of amputation: (b)(6) 2011; (right, knee).
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incident(s) against the provided product/lot combination(s) since release for distribution.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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Search Alerts/Recalls
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