Model Number N/A |
Device Problem
Migration (4003)
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Patient Problems
Rheumatoid Arthritis (1724); Bone Fracture(s) (1870); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).(b)(6).Unique identifier (udi) #: n/a.Customer has indicated that the product will not be returned to zimmer biomet for investigation, remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient was recommended for a revision of the right elbow due to patient bone fracture and loosening of implant.Attempts were made and no additional information is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Concomitant medical products: unknown humeral stem ¿ unknown part unknown lot therapy date: unknown.(b)(4).Reported event was confirmed by review of x-rays provided.Review of x-rays notes ossific material adjacent to the proximal ulna medially and anteriorly reflecting prior fracture or heterotopic ossification.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08563.
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Event Description
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It was reported that the patient underwent a revision of the right elbow due to patient bone fracture and loosening of implant at an unknown amount of time post implantation.Attempts were made and no additional information is available at this time.
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Search Alerts/Recalls
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