Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cellulitis (1768); Erythema (1840); Fever (1858); Necrosis (1971); 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; 110029938 compr srs 50mm dst hum bdy rt 213040; unknown nexel ulnar component ; unknown nexel articulation kit.(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: 0001825034 - 2018 - 11344; 0001825034 - 2018 - 11347.
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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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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, accompanied with increased pain, drainage, fever, necrotic tissue and swelling six weeks post implantation.It was reported that the infection was related to procedure but not implants.Antibiotic beads were placed; no implants were revised.No additional information was provided.
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Manufacturer Narrative
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The following report is being submitted to relay additional information received.The complaint was confirmed based on the medical records stating patient underwent an id procedure.Review of device history records found no deviations or anomalies.Root cause could not be determined; however, it is noted that diabetes, obesity, and cancer history all contribute to delayed wound healing and predispose the patient to infection.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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