Model Number N/A |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Same/ similar to k182964.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 that while using the rosa platform during a tka surgery, there was an over resection of tibia by 3mm.A thicker than expected poly implant had to be used.No additional consequences or impact to the patient.It was reported that no further information is available.
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Search Alerts/Recalls
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