Catalog Number 999800754 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Cyst(s) (1800); Death (1802); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Pocket Erosion (2013); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/15/2019 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Initial reporter occupation: lawyer.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 the patient had an asr cup, sleeve and head done over 10 years ago in (b)(6).The surgeon took out asr head sleeve and cup, and put in new pinnacle multihole shell, screw, liner and head.Doi: over 10 years ago.Dor: (b)(6) 2019; left hip.
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Manufacturer Narrative
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Product complaint # (b)(4).Added death determination (b2), additional information in event description (b5), and patient code (h6).The information pertaining to the death was received from a litigation source only.No further information is available at this time.An additional supplemental report will be submitted if more information is received 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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Plaintiffs claim damages as a result of injury due to decedent's failed depuy asr hip implant, including economic damages and wrongful death.After the implantation, the decedent suffered the following personal and economic injuries as a result of the implantation with the asr hip implant: severe pain, elevated metal levels, emotional injuries, trouble sleeping and walking, and ultimately death.
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Event Description
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Patient experienced fatigue and has inflammation.Revision notes stated that there was a large hemorrhagic cyst.The hemarthrosis and sanguinous filled cyst was drained.There was also erosion of bone of the superior and posterior acetabulum.There was also some erosion of the upper femur with some hairline nondisplaced fracture of the greater trochanter and bone loss on the acetabulum.Doi: (b)(6) 2009, dor: (b)(6) 2019, (left 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.H10 additional narrative: h6 clinical code: appropriate term / code not available (e2402) is used to capture injury (e20).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: 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: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched 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: 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: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.
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Search Alerts/Recalls
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