Model Number N/A |
Device Problems
Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Loosening of Implant Not Related to Bone-Ingrowth (4002)
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Patient Problems
Pain (1994); Swelling (2091)
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Event Date 12/24/2020 |
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: 0001825034-2021-00070.Concomitant medical products: vgxp xp e1 tib brg rm 9x71 item# 195849 lot# 701780, vgxp xp inlk pri tib tray 71mm item# 195755 lot# 780210, vgxp intlk femoral rt 65 item# 195910 lot# 378420.Report source: (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.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 approximately five years and five weeks post implantation due to pain, swelling, and loosening of the articular surfaces.After the initial surgery, the patient experienced pain and swelling on his knee and went to see a doctor.Surface loosening was confirmed by the diagnosis.A revision was performed to replace the surfaces with thicker ones.There is no additional information at this time.
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Event Description
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It was reported that a patient felt a pain on her operated knee joint and swelling was confirmed on her knee.The surgeon suspects wear and deformation on the articular surface because the patient activity was very high.As a result, a revision was performed to replace the articular surface.
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Manufacturer Narrative
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This follow-up is being submitted to correct previously submitted information.Updated: b4, g4, g7, h1, h2, and h10.Corrected: b5, h6.
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Manufacturer Narrative
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No product was returned or pictures provided; therefore, visual and dimensional evaluations could not be performed.X-ray images were provided but not sent to mmi for radiologist review because the poly and soft tissue structures are not visible on x-ray and no other components were revised.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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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