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Model Number N/A |
Device Problems
Corroded (1131); Material Discolored (1170)
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Patient Problems
Cellulitis (1768); Unspecified Infection (1930); Irritation (1941); Nerve Damage (1979); Pain (1994); Swelling (2091); Reaction (2414)
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Event Date 04/17/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as they were discarded by hospital.Concomitant medical products: 47235800505, distal posterior/lateral humeral plate right 5 holes 98 mm length, 62685139, 47235810703, dist med hum lk plt shrt 3h rt, 61153867, 47482802402, 2.7 mm locking screw 24 mm length, 62569488, 47482802002, 2.7 mm locking screw 20 mm length, 63062886, 47482803002, 2.7 mm locking screw 30 mm length, 62881175, 47482803002, 2.7 mm locking screw 30 mm length, 62881175, 47482801802, 2.7 mm locking screw 18 mm length, 63470831, 47482802002, 2.7 mm locking screw 20 mm length, 62565038, 47482802202, 2.7 mm locking screw 22 mm length, 62634798, 47482801402, 2.7 mm locking screw 14 mm length, 63510330.G3 - report source, foreign - the event occurred in the (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 02571, 0001822565 - 2018 - 02572, 0001822565 - 2018 - 03249, 0001822565 - 2018 - 03250, 0001822565 - 2018 - 03251, 0001822565 - 2018 - 03253, 0001822565 - 2018 - 03254, 0001822565 - 2018 - 03255, 0001822565 - 2018 - 03256 , 0001822565 - 2018 - 03257.Not returned to manufacturer.
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Event Description
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It was reported that the patient was revised due to ulnar nerve symptoms.Two months prior to removal, patient presented with symptoms: warm, swollen, erythematous and crp <8.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.
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Event Description
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It was reported that the patient was revised due to ulnar nerve symptoms and infection.Two months prior to removal, patient presented with symptoms: infection, warm, swollen, erythematous and crp less than 8, which were treated with 2 separate courses of oral antibiotics.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of pictures of product provided and pathology report.As per the pathology report, adverse reaction to metallic debris/metallosis has been noted.But, there is no date of when the specimens were taken or pathology report.Dhr was reviewed and no discrepancies 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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It was reported that the patient was revised due to ulnar nerve symptoms and infection.Two months prior to removal, patient presented with symptoms: infection, warm, swollen, erythematous and crp less than 8, which were treated with 2 separate courses of oral antibiotics.During removal of the plate, rust or discoloring were identified on the plate and screws.Metallosis was also noted.Attempts have been made and additional information on the reported event is unavailable.
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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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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.One screw was returned for evaluation.The visual inspection noted discoloration on the product.The screw was sent to scanning electron microscope (sem) for additional evaluation - energy dispersive x-ray spectroscopy (eds) semi-quantitative elemental analysis of the discoloration indications on the products revealed c, n, o, na, mg, p, cl, k, and ca as the major foreign elements.Signs of pitting corrosion observed within the locking threads on the screw.The eds analysis of the discoloration free area on the locking screw noted the screw material is conforming to specifications.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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Search Alerts/Recalls
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