Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Osteopenia/ Osteoporosis (2651)
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Event Date 02/06/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical device: oxf twin-peg cmntd fem lg pma; item# 161470; lot# 372730.Oxf anat brg lt lg size 3 pma; item# 159554; lot# 561070.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 - 2023 - 00056, 3002806535 - 2023 - 00058.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
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Event Description
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It was reported, that the patient underwent a left partial knee arthroplasty and approximately 5 years later a revision surgery was performed due to pain.Contributing factor was disease progression.Attempts have been made and no further information has been provided.
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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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(b)(4).This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Devices are used for treatment.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: four views of the left knee demonstrate tricompartment osteophytosis and medial compartment narrowing.Spurring of the tibial spines.Patellar osteophytosis.No fracture.Three views of the left knee demonstrate interval medial compartment hemi arthroplasty involving the left knee with no radiolucency.No fracture.Small to moderate joint effusion.Single ap film of the left knee demonstrates persistent medial compartment hemi-arthroplasty with possible subsidence of the component medially along with cortical irregularity of the proximal tibial metaphysis medially in this region.Worsening lateral compartment narrowing also seen.Osteopenia.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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