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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Tingling (2171); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
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Event Date 01/27/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: 211254, compr srs 60mm dst hml bdy rt, 952960, 114817, disc ulna 3x115mm rt w/brng c, unknown, 211236, compr srs mod stem - 8x100mm, 635430, 211270, compr srs large flange, 916200/ 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.X-rays were submitted to mmi for review.Overall fit and alignment of the implants is appropriate.There is likely osteopenia present.Radiolucency is noted along the ulnar component which is suggestive of loosening.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 - 04150, 0001825034 - 2018 - 04151, 0001825034 - 2018 - 04152, 0001825034 - 2018 - 04154.Product location unknown.
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Event Description
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It was reported that the patient underwent right shoulder arthroplasty.During a one and three year follow up appointment, the patient experienced moderate to severe pain, difficulty sleeping, moderate tingling, difficulty opening a jar, difficulty doing heavy chores, difficulty carrying a bag, difficulty cutting, washing back, limited in social activities, and limited/ unable to do daily and recreational activities.Attempts have been made and additional information on the reported event is unavailable.
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Search Alerts/Recalls
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