Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Defective Component (2292)
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Patient Problems
Osteolysis (2377); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The complaint number corresponding to this medwatch is (b)(4).It is unknown if the device will 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.Unknown head, unknown liner & unknown stem.
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Event Description
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It was reported that the patient's left hip has been indicated for revision due to loosening and acetabular defect.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported a patient underwent hip revision due to acetabular loosening as a result of bone loss.The acetabular shell and liner were revised.No further information is available.
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Search Alerts/Recalls
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