ZIMMER MANUFACTURING B.V. LINER 28 MM I.D. FOR USE WITH 50/51/52 MM O.D. SHELLS; PROSTHESIS, HIP
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Model Number N/A |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Joint Dislocation (2374)
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Event Date 11/11/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: zimmer cat# 00-7850-013-00 lot 65299499 stem zimmer cat# 00-7859-010-00 lot 65353398 stem centralizer.The device will not be returned for analysis, as the device was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 -2022 -00250.0002648920 -2022 -00251.
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Event Description
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It was reported the patient underwent a left initial hemiarthroplasty that was subsequently revised approximately 3 (three) months later due to dislocations from recurrent falls.The shell, liner, and head were exchanged without complications.Attempts have been made and the additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: through follow up visits, the patient reported suffering from recurrent falls with repeated dislocations and instability.It was decided to convert to total hip and the patient was revised.The shell, head, and liner were replaced, no complications noted.Review of the device history records identified no deviations or anomalies during manufacturing.It was noted the patient suffered from recurrent falls leading to dislocations.As the reason for the falls are unknown, a definitive root cause cannot 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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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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