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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Pain (1994)
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Event Date 11/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device remains implanted and will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-03480 0001822565-2023-03466 0001822565-2023-03474.
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Event Description
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It was reported that approximately nine years post implantation of a right total hip arthroplasty, the patient received a cortisone shot due to pain.It was reported that the initial pain came from a stretching exercise, and the pain was both weight bearing and non-weight bearing.The patient had also sustained three falls within a six-month period.There was no information available related to how the falls occurred.The surgeon determined that the patient had a right hip strain and was treated with a cortisone injection in the right hip bursa.No further complications have been reported.No additional information is available.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04): head.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.The reported products were reviewed for compatibility with no issues noted.Medical records were provided and reviewed by a health care professional.A review of the available records identified the following: an initial right total hip arthroscopy was performed, and approximately nine years later, the patient reported three falls in six months with pain.Cortisone injections were provided; however, the pain persisted.Radiographs were also provided and reviewed by a health care professional.A review of the available records identified the following: anatomic alignment of the right hip arthroplasty.It was reported the patient fell multiple times and began experiencing pain.As the reason for the falls were unknown, a definitive root cause cannot be identified.The reported issue was confirmed based on the provided medical records.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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No further event information is available at the time of this report.
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Search Alerts/Recalls
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