Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Failure of Implant (1924); Pain (1994)
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Event Date 06/22/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Medical products; oxf anat brg lt x-sm sz 3 pma , item# 159790 , lot# 600760.Oxf uni tib tray sz aa lm pma , item# 159531 , lot# 105880.Multiple mdr reports were filed for this event, please see associated reports: 3002806535 -2022 -00385.3002806535 -2022 -00386.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 the patient underwent a left knee revision 27 months post-implantation due to pain.Due diligence is in progress for this complaint; to date no additional information or product has been received.
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Manufacturer Narrative
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(b)(4) this follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, g3, g6, h1, h2, h6, h10 review of the device history records identified no deviations or anomalies during manufacturing.Devices are used for treatment.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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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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