Model Number 1218-87-354 |
Device Problems
Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Foreign Body Reaction (1868)
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Event Date 02/04/2022 |
Event Type
Injury
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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 on (b)(6) 2009, the patient underwent the tha surgery for oa with the implants in question.After the surgery, on (b)(6) 2022, it was confirmed that suspected armd and suspected corrosion.Revision surgery occurred (b)(6) 2022.The head was removed and replaced with new smaller one.The stem was also eroded and removed.The stem was replaced with new bigger one.Doi: (b)(6), 2009, dor: (b)(6) 2022.Unknown hip.
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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: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Search Alerts/Recalls
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