Model Number N/A |
Device Problem
Component Incompatible (1108)
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Patient Problem
No Information (3190)
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Event Date 03/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: medical product:oxf uni cmntls tib sz c lm, catalog #: 166574, lot #: 6445866, medical product: oxford ph3 cementless fem sz s, catalog #:154925, lot #:6407586.Report source: (b)(6).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 has been reported by the hospital that a patient underwent an initial partial knee replacement procedure.Subsequently, after the surgery, upon implant sheet inspection, the sales representative has noticed that a size small femoral component had been used with an extra small meniscal bearing.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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It has been reported by the hospital that a patient underwent an initial partial knee replacement procedure.Subsequently, after the surgery, upon implant sheet inspection, the sales representative has noticed that a size small femoral component had been used with an extra small meniscal bearing.
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Search Alerts/Recalls
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