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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
Wound Dehiscence (1154)
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Event Date 12/15/2020 |
Event Type
Injury
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Event Description
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It was reported that the patient was revised due to wound dehiscence and deep hip seroma with swelling and serosanguineous fluid approximately 2 weeks post revision surgery.During the revision tissue sent for cultures, results pending, and debridement of adhesions.Wound vac placed and iv antibiotics until culture is negative.Stopped dvt anticoagulants due to wound complications.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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(b)(4).Concomitant medical products: catalog number: 192411, lot number: 219480, brand name: echo por fmrl red.Catalog number: us157862, lot number: 315260, brand name: m2a-magnum pf cup.Catalog number: 650-1065, lot number: unknown, brand name: cer option type 1 tpr.Catalog number: 110031006, lot number: unknown, brand name: longevity dm bearing.Catalog number: 650-1055, lot number: unknown, brand name: cer bioloxd option hd.Multiple reports were submitted along with this report: 0001825034-2022-00608.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.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.The root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device.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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Search Alerts/Recalls
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