Device Problems
Accessory Incompatible (1004); Device-Device Incompatibility (2919); Appropriate Term/Code Not Available (3191)
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Patient Problems
Failure of Implant (1924); No Information (3190)
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Event Date 05/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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Customer indicated that there is no product/device to be returned for investigation analysis.
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Event Description
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It was reported a revision was performed due to unspecified reasons.Surgical delay of two hours also occurred.
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Manufacturer Narrative
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The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
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Event Description
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It was reported that surgeon needed to revise the whole total hip because revising only the sleeve of the stem is no longer possible since the component is no longer manufactured and well fitting femoral stem needed to be removed also.Due to difficulty with removing the stem the surgical time was extended.
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Search Alerts/Recalls
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