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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/02/2022 |
Event Type
Injury
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Event Description
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It was reported the patient underwent a left hip procedure at an unknown date.Subsequently, the patient was revised due to unknown reasons.A new stem, liner and head were implanted.No further event information available at the time of this report.
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Manufacturer Narrative
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(b)(4).No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00892 and 0001825034 - 2022 - 00893.
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Search Alerts/Recalls
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