Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(6).Products have been received by zimmer biomet and the investigation is in process.Once the investigation have been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01301, 0001825034-2020-01303, 0001825034-2020-01304.
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Event Description
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It was reported that during a hip procedure, the products bent, twisted and fractured during use.It is unknown if there was any harm or injury sustained by the patient.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected.Updated: g4; h2; h3; h6.Complaint sample was returned and evaluated against the complaint.Multiple devices were returned and visual inspection of one item number (b)(4) was fractured and blackened.The second item number (b)(4) was intact but had been blackened with debris in the tip.Item number (b)(4) had the tip worn and blackened.Item number (b)(4) was returned with the tip showing damage and discoloration.Item number (b)(4) was returned fractured into two pieces.Dhr was reviewed and no discrepancies were found.A definitive root cause is 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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