Catalog Number UNK HIP FEMORAL AUGMENT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Pain (1994); Tissue Damage (2104); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 04/18/2017 |
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.Device was used for treatment, not diagnosis.510k: this report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Litigation alleges injury,metallosis, bone loss, and metal debris, pain, suffering, emotional distress, and elevated cobalt and chromium level.Doi: (b)(6) 2006 - (b)(6) 2017 (left hip).
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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.(b)(4 used to capture the medical device removal.
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Event Description
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Medical records received.After review of medical records, the patient was revised to address aseptic loosening secondary to metallosis.Patient had a massive fluid collection visualized on mri and significant bone loss in the periacetabular and periproximal femoral area and pain prior to revision.Intraoperatively, massive metallosis debris was encountered.There was evidence of trunnionosis with dark staining of both the trunnion and the femoral head.The acetabular component was grossly loose.The stem was well fixed and well positioned.There was significant bone loss.Doi: (b)(6) 2006 - dor: (b)(6) 2017 (left hip).
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary = > this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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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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: product complaint # (b)(4).Investigation summary: this hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Further investigation of this individual incident will not be undertaken.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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Search Alerts/Recalls
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