Catalog Number 121887352 |
Device Problems
Metal Shedding Debris (1804); Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
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Patient Problems
Fatigue (1849); Foreign Body Reaction (1868); Pain (1994); Tissue Damage (2104); Distress (2329); Discomfort (2330); Injury (2348); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189)
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Event Date 08/25/2017 |
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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Pinnacle litigation records received.Litigation alleges progressively worse pain, lack of mobility, emotional distress, metallosis and elevated metal levels of cobalt and chromium.Revision note reported, on the femoral side there was a significant degree of bone loss.There was a large black stained on mass on the lateral aspect of the greater trochanter, this was filled with metal debris.There was a pathologic fracture at the base of the greater trochanter.The acetabular component was grossly loose and there was pronounced metal staining of the remaining native acetabulum and surrounding soft tissues.There was almost complete loss of the anterior column and severe thinning of the posterior column.Radiograph shows some osteolysis with an area of lucency at the acetabular medial wall.Laboratory results for blood metal ion level shows above 7 ppb.Doi: (b)(6) 2008 : dor: (b)(6) 2017; (left hip).
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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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up 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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Event Description
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Pfs alleges discomfort and fatigue.
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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. udi: (b)(4).
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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 device manufacturing (mre) review will not be performed even when product/lot information is known.It has been determined that, for the mom platform and related allegations an mre is not required.
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Search Alerts/Recalls
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