Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Joint Dislocation (2374)
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Event Date 09/20/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated report: 0001822565-2023-02796, 0001822565-2023-02798.D10-medical product: polyethylene insert xt size b.Item# 00585001296.Lot# 65322745.Articular surface with segmental hinge post size b 20 mm height.Item# 00585002020.Lot# 64314434.G2- south africa.H3- customer has indicated that the product will be returned to zimmer biomet for investigation.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 a patient was revised a little over two months post implantation due to pain, dislocation, and implant fracture.The patient contacted the surgeon to discuss discomfort and pain in his left knee.The surgeon suggested that he go for x-rays at the nearest hospital.The result of the x-rays showed a clear dislocation of the left knee.It is also visible that the hinge post and bushings were fractured.Attempts to obtain additional information have been made; however, no more information is available at this time.
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Manufacturer Narrative
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This follow-up is being submitted to relay additional information.
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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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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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This follow-up is being submitted to relay additional information.Visual examination the returned stem segment shows no functional damage, and images provided from revision surgery shows it was functioning as intended.Medical records were not provided however, x-ray images were provided but not dated, and would not enhance the investigation process.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint can be confirmed from the fractured implants that were returned.No problem was found with the returned stem.If any further information is received which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.H6: component code: proposed component (annex g) code is: - mechanical (g04) stem.
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Search Alerts/Recalls
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