Model Number 3L92512 |
Device Problems
Inaccurate Information (4051); Wrong Label (4073)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/25/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 has been reported that customer is complaining the color-coding at the outer package of corail stems.As per surgery technique the green marking at the outer package indicates a 135° offset.Now the customer received a stem with 135° offset that shows a blue marking.As per surgery technique the blue marking should indicate a 125° offset.
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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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation revealed enough evidence to confirm the reported allegation.The colored marking is incorrect.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found 1 unrelated past nc¿s associated with this product/lot combination.However an nc was raised to address the current complaint issue.1) quantity manufactured: (b)(4) parts , 2) date of manufacture: 26 september 2022, 3) any anomalies or deviations identified in dhr: 1 non-conformance associated with this lot, however there is no correlation between this non-conformance and the failure mode of the complaint.4) expiry date: 31 august 2027, 5) ifu reference: w90918 ifu corail 2 hip stem.Device history review : 1) quantity manufactured: (b)(4) parts 2) date of manufacture: 26 september 2022 3) any anomalies or deviations identified in dhr: 1 non-conformance associated with this lot, however there is no correlation between this non-conformance and the failure mode of the complaint.4) expiry date: 31 august 2027.5) ifu reference: w90918 ifu corail 2 hip stem.
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Search Alerts/Recalls
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