Catalog Number 999800760 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Event Date 07/29/2015 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Update ad 21 jul 2022: (b)(4) has been reopened under (b)(4) due to the receipt of asr litigation record.Patient alleges discomfort, elevated metal ion, emotional distress, disability, and economic damages.Added lawyer and law firm.Corrected patient initials.Added concomitant products in ip and pc level.Occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Litigation papers allege pain, stiffness, bodily injuries, and disfigurement.Doi: (b)(6) 2008, dor:(b)(6) 2015, (right side).
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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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Event Description
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Pdf, ppd and medical record received.The record reported elevated metal ions in the left hip.Since this is systemic harm and a recall.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: update (b)(6) 2022 no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: device history reviews for asr platform have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: update 4-oct-2022.No device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: previous investigations that have included device history reviews since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.Therefore, if lot codes are provided, no dhr (device history record) review or complaint database search for this individual asr component will be carried out at this time.
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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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Event Description
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Pfs alleges stiffness, limited adl, elevated metal ions, pain, emotional distress and anxiety.After review of the medical records there was no new information to be updated in the complaint.Doi: (b)(6) 2008 , dor: (b)(6)2015, right hip.
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Search Alerts/Recalls
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