Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Fever (1858); Pain (1994); Swelling (2091); Post Operative Wound Infection (2446)
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Event Date 10/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 211225 compr srs ic seg - 60mm 875550, 211238 compr srs mod stem - 12x100mm 653050, 110029938 compr srs 50mm dst hum bdy rt 213040, unknown nexel ulnar component.(b)(6).The complaint is under investigation.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: 0001822565 - 2018 - 06972.
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Event Description
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It was reported that the patient underwent an initial right distal humeral resection and implantation of a distal humerus and elbow arthroplasty.Subsequently, the patient experienced superficial wound infection two weeks post implantation and underwent an irrigation and debridement procedure for deep wound infection six weeks post implantation.It was reported that the infection was related to procedure but not implants.No additional information was provided.
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Manufacturer Narrative
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The complaint is under investigation.Once the investigation is completed a follow up report will be submitted.
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Event Description
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No additional information is made available at this time to report.
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Event Description
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No additional information is available to report at this time.
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Manufacturer Narrative
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The following report is being submitted to relay additional information received.Udi: (b)(4).The complaint can be confirmed based on the medical records provided stating patient admitted from emergency department due to right elbow wound drainage, fever, swelling, and increased pain.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definite root cause cannot be determined with the information provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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