Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Code Available (3191)
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Event Date 05/12/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Udi #: (b)(4).Foreign report source: (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00390.
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Event Description
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It was reported a patient had an initial right tka.Eight months after the procedure the patient was revised due to dislocated liner and implant wear.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records / radiographs were provided and reviewed by a healthcare professional.Review of the available records identified the following: liner wear and dissociation was noted.A definitive root cause cannot 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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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