Catalog Number 866499 |
Device Problem
Wrong Label (4073)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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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 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
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Event Description
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It was reported that the incorrect label was on the box.
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Event Description
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Additional information received: a.Was/were there any adverse consequence/s that affected the patient because of the reported event? - no, it was discovered during inventory management.
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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).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: wrong label or-code, wrong qr -code, label : art: 86-6499 13x 150 cemented stem lot d 16122525, qr -code as well ean code says 15 x 150 cemented stem, notice when i was cycle account.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the taper cem stem 13x150mm box was found in good condition, and the labeling on the package is correct.However, the problem was identified as a data error within the esims system.This product issue will be addressed through depuy synthes quality system.A dimensional inspection was unable to be performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the taper cem stem 13x150mm would contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: dhr review: 1) quantity manufactured: (b)(4).2) date of manufacture: 04-feb-2017.3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 31-jan-2027.5) ifu reference: ifu-0902-00-252 h3.
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Search Alerts/Recalls
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