Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Post Operative Wound Infection (2446)
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Event Date 01/28/2019 |
Event Type
Injury
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Manufacturer Narrative
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Udi: (b)(4).Concomitant medical products: 115738 compr nano hmrl pps 38mm 696790; 118001 versa-dial/comp ti std taper 170590; 113954 md hybrid glenoid base 4mm 984350; pt-113950 pt hybrid glen post regenerex 066130.Report source- foreign- (b)(6).Investigation 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 - 2019 - 00895; 0001825034 - 2019 - 00897; 0001825034 - 2019 - 00900.
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Event Description
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It was reported that the patient had initial shoulder arthroplasty, and subsequently experienced superficial surgical incision infection one month post implantation.The patient was prescribed antibiotics, and the dehiscence was noted to be improving within one month of treatment.No additional information is available at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Dob - unknown month and day in 1946.Reported event was confirmed by review of follow up visit notes.As per first follow up notes, the patient presented today after having a wound discharge and dehiscence of the upper 1 cm of the scar, which developed 1 week back and patient does not show any signs of infection around the wound, no tenderness.On the second follow up the wound still has a bit of dehiscence proximally but no longer draining and appears much healthier.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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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