Model Number N/A |
Device Problems
Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported that a patient will be undergoing a revision of a hip implant due to unknown reasons.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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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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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.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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