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Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Claudication (2550)
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Event Date 06/26/2014 |
Event Type
Injury
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Manufacturer Narrative
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Zimmer biomet complaint: (b)(4).Medical product: vanguard xp femoral interlok with pegs catalog# 195214 lot# 990240, vanguard xp tibial bearing-left lateral catalog# 195367 lot# 677800, vanguard xp tibial bearing-left medial catalog# 195437 lot# 825590.The device was not returned for evaluation due to unknown location.Review of the device history record (dhr) found no deviations or anomalies.Review of complaint history for same or similar issue identified seven additional complaints for part (item) number and three additional complaints were identified for part/lot combination.Without the opportunity to evaluate the device, the complaint was not confirmed and root cause could not be determined.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Associated risk table lists "miscellaneous user needs (general post-operative pain )¿.Following review, no new risks were identified.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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-01255/01258/01259.This report is being submitted late as it has been identified in remediation.
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Event Description
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It was reported as part of a clinical study that a patient underwent a left knee procedure on (b)(6) 2014.Subsquently, the patient reported moderate pain, problems with walking and performing daily activites, often limping, and difficulty using stairs during the six (6) month, one (1) and two (2) year follow up visits.It was also reported that the patient was still using a cane 2 years post implant.Attempts have been made and no further information has been provided.
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Search Alerts/Recalls
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