Model Number N/A |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product has been received by zimmer biomet.The investigation is currently in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was reported that the pps coating was not consistent with the size.The 14 coating measured a 13.75.There is no additional information available at the time of this report.
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Event Description
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There is no update to the prior event description provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.One arcos 14x175mm brch body hi item# 11-304014 lot# 65688729 was returned and evaluated.Upon visual inspection the face above the threaded hole had fractured.Its unknown when the damage occurred, the product was measured and found to be conforming.A review of the device history records identified no related deviations or anomalies during manufacturing.Medical records were not provided.The investigation could not verify or identify any evidence of product contribution to the reported problem.The event is not confirmed based on returned product measurements.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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Search Alerts/Recalls
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