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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Impaired Healing (2378)
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Event Date 04/25/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog#: 010000665, g7 pps ltd acet shell 56f, lot#: 6883509; catalog#: 20103606, g7 longevity neutral 36mm f, lot#: 64922355; catalog#: 650-0661, delta ceramic fem hd 36/0mm, lot#: 3035179.The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01510, 0001822565-2021-01365.
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Event Description
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It was reported that the patient underwent a left total hip arthroplasty, subsequently, at three days post op, the patient returned to the emergency department for wound dehiscence.Medical intervention was provided.Resolution of the event is pending.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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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.In this case the wound was noted to separate at the distal portion however healed without surgical intervention.This deviation signifies an alteration in the wound healing process.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device; therefore, a review of the device history records will not be performed.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 available at the time of this report.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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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Search Alerts/Recalls
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