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Catalog Number 118001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Wound Dehiscence (1154)
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Event Date 09/08/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: compr nano hmrl pps 34mm cat#115734 lot# 085930.Versa-dial 42x18x46 hum head cat# 113032 lot# j7236572, 4 peg mod glen sz 5 cat# sagl2045 lot# 65054832, modular post tm cat# sagp0002 lot# 65169769, unk palacos mv cement cat#ni lot#ni.Foreign source: canada.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 02224, 0001825034 - 2022 - 02226.
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Event Description
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It was reported that a patient was found to have wound dehiscence 1 month post implantation of a left total shoulder arthroplasty.The patient was prescribed oral antibiotics and is to follow up again in clinic.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.It was reported a patient had a shoulder arthroplasty.Subsequently, one month later, experienced wound dehiscence and was prescribed prophylactic antibiotics.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression ¿wound concerns¿ or ¿non-healing wound¿ would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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