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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Ambulation Difficulties (2544)
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Event Date 04/14/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown, unknown comprehensive srs flange, unknown, 211266, compr srs anti rot ic seg-30mm, 118810, 211236, compr srs mod stem - 8x100mm, 027570, 211251, compr srs 60mm dst hml bdy lt, 457210, unknown, unknown discovery humeral condyle kit, unknown.Report source, foreign - the event occurred in the (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the part and lot numbers of the device involved in the event are unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.This report is being submitted late as it has been identified in remediation.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01204, 0001825034-2018-01205, 0001825034 - 2018 - 04109, 0001825034 - 2018 - 04110, 0001825034 - 2018 - 04111.Product location unknown.
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Event Description
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It was reported that a patient underwent left elbow arthroplasty.Subsequently, post-operative pain and the following experiences were reported at the follow up visits via the quickdash questionnaire: 6 month - severely difficult to open jar, severely difficult to do heavy chores, moderately difficult to carry bag, moderately difficult to wash back, moderately difficult to cut, unable to do recreational activities, moderately limited with daily activities; 1 year - unable to open jar, moderately difficult to do heavy chores, moderately difficult to carry bag, moderately difficult to wash back, severely difficult to do recreational activities; 3 year - unable to open jar, unable to do heavy chores, unable to wash back, moderately difficult to cut, unable to do recreational activities and moderately limited in daily activities.No additional information available.
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Search Alerts/Recalls
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