Model Number 420915 |
Device Problems
Incorrect Measurement (1383); Patient-Device Incompatibility (2682)
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Patient Problems
Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that the after cutting tibia the slope was 14 degrees instead of the planned 3 degrees.Patient¿s natural tibia slope on the plan was 17 degrees.Surgeon did not use recommended 1.19mm whale tail.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5, e1 (initial reporter facility name) and h6 (impact code).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: b3.
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Event Description
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Additional information was stating that the surgical delay would have been 10-15 minutes requiring the recuts.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with the reported event was not returned for evaluation.The investigation could not confirm the reported event.Segmentation is designed within trumatch specifications and no issues were identified.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.Device history lot : dhr reviewed, no deviations or nonconformance's were noted.Device history review : dhr reviewed, no deviations or nonconformance's were noted.
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Search Alerts/Recalls
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