Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Perforation (2001)
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Event Date 07/28/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products- comprehensive srs modular stem catalog#:211241, lot#:unk, and unknown biomet comprehensive shoulder components.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-05056.Customer has indicated that the device will not be returned for evaluation, as the device 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 had initially underwent a right reverse shoulder arthroplasty.Subsequently, twenty one (21) days post-operatively, it was reported that the patient suffered a humeral fracture or perforation.The patient underwent cement extraction procedure from elbow for treatment and the issue was successfully resolved.The issue was reported to be not device related, but possibly procedure related.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.The following sections were updated: (b)(6) date of this report - (b)(6) 2017; date received by manufacturer - aug 23, 2017; type of report - follow-up 1; if follow-up, what type - correction, additional information.The following sections were corrected: date of birth - (b)(6) 1953.Date of event - (b)(6) 2015.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 - 2017 - 05056 - 1.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.(b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were reviewed but could not confirm the reported event.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action is required as no were trends identified.Root cause could not 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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Manufacturer Narrative
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(b)(4).This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Radiographs were reviewed but could not confirm the reported event.Dhr was reviewed and no discrepancies were found.Root cause could not 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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