Catalog Number 00801803202 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Bone Fracture(s) (1870); Non-union Bone Fracture (2369); Insufficient Information (4580)
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Event Date 08/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2023-00200.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 two 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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Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The patient underwent a revision due to periprosthetic fracture and non-union.The initial report should be voided.
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Manufacturer Narrative
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(b)(4).Upon receiving additional information of the reported event, it was determined to be not reportable as this product was not involved in the event.The initial report should be voided.
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Search Alerts/Recalls
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