Model Number 1219-28-148 |
Device Problems
Disassembly (1168); Material Separation (1562); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)
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Event Date 09/27/2016 |
Event Type
Injury
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Manufacturer Narrative
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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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Depuy16-44.On (b)(6) 2007 the patient was subjected to a right arthroplasty in which received a pinnacle implant.Due to an atraumatic detachment of pinnacle coating, the implant was replaced with an asr implant.In the following years the patient suffered pain / lameness/ diastolic dysfunction/ musculare hypotrophy /mtral failure / atrial dilatation / high level of cr/co in blood/etc.Update 28 sept 2016 - the patient suffered the above issues after the revision surgery.The primary intervention was performed on (b)(6) 2007 (i wrote (b)(6) 2007 by mistake: (b)(6) 2007 was the first hospitalization date) and the revision surgery was performed on (b)(6) 2007.Update nov 30, 2017: additional information received.Updated pinnacle cup and added the head, stem and liner products.This complaint was updated on: dec 8, 2017.
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Manufacturer Narrative
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No device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.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.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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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.
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Manufacturer Narrative
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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.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.Addendum added (b)(6) 2020.No device associated with this report was received for examination.A worldwide complaint database search found no additional related incident(s) against the provided product/lot combination(s) since release for distribution.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.Corrective action was not indicated.It was noted that this product had a manufacturing date of 12-march-2007, with an expiry date of february-2012.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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Manufacturer Narrative
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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.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.
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Event Description
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Scf alleges discomfort.Patient was revised due to an atraumatic detachment of pinnacle coating.This was previously coded in legacy record with implant disassociation change to wear.
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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.No code available (3191) used to capture device revision or replacement.
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Manufacturer Narrative
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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. h10 additional narrative: added: h4 and h6 (patient codes) h6 patient code: no code available ((b)(6)) used to capture the walking difficulty.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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Search Alerts/Recalls
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