Catalog Number 00801803201 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).G2: australia.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 will be submitted.
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Event Description
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It was reported a patient underwent a hip revision approximately three years post implantation for unknown reasons.Attempts have been made and no further information is available.
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Event Description
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It was reported a patient underwent a hip procedure approximately nine months post implantation due to a periprosthetic fracture and non-union with significant plating/screw use and a head exchange.It was reported that no further information is available.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Upon receipt of patient's medical records, it was confirmed that the patient underwent a revision due to periprosthetic fracture and non-union of the bone.The femoral head was only removed because the patient was being revised; no allegations against the head.Therefore, this component is now considered not reportable.
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Search Alerts/Recalls
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