ZIMMER BIOMET, INC. TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 13 MM THICKNESS; PROSTHESIS, KNEE
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Model Number N/A |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The product has been returned to zimmer biomet for investigation.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 was reported that a tasp shim was returned missing bearings.Attempts to obtain additional information have been made; however, no more information is available.
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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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This follow-up is being submitted to relay additional information.Visual examination of the returned product found, it to exhibit signs of repeated use.And it is disassembled.Medical records were not provided.Device history record (dhr) was reviewed for deviations, and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is 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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