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Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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A possible broken or dislocated slide-loc device was reported.Per information received, the device was implanted 6 years ago (exact implant date unknown).The patient heard a "pop" (event date unknown) and presented to the clinic on (b)(6) 2022.Scheduling of a revision procedure was pending.Attempts to obtain further information regarding the patient, revision procedure date, and device information were made to no avail.This report is for the slide-loc stem and is related to report numbers 3025141-2022-00150 and 3025141-2022-00151 for the head and neck respectively.
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Manufacturer Narrative
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The results of the investigation are inconclusive as the device was not returned for evaluation.Manufacturing and inspection records could not be reviewed as batch/lot number is unknown.A recall had been initiated for this device in 2017: https://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfres/res.Cfm?id=154986.
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Search Alerts/Recalls
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