Catalog Number N/I |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Joint Dislocation (2374); Insufficient Information (4580)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Source: (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient is being considered for a revision due to unknown reasons.However, no revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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It was reported that the patient is being considered for a revision due to instability of the acetabular cup and joint dislocation approximately 7 months post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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D10: unknown liner, unknown head.Multiple reports were submitted along with this report: 0001825034-2022-01524, 0001825034-2022-01525.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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Radiographs were provided and reviewed by a health care professional.Review of the available records identified left total hip arthroplasty with dislocation of the acetabular cup, medial acetabular wall fracture and acetabular protrusio.The bone fracture likely caused the cup instability.Reported event was confirmed by review of x-rays provided.Device history record (dhr) review was unable to be performed as the item and lot number of the device involved in the event is unknown.Root cause could not be determined.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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Search Alerts/Recalls
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