Catalog Number UNK HIP FEMORAL STEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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Product complaint # (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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Pinnacle litigation records received alleging that the patient developed an infection of the surgical area shortly after the surgery leading to injury, disability, disfigurement, pain and suffering.Doi: (b)(6) 2017 - dor: not indicated, (left hip).
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).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 medical device removal and surgical intervention.
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Event Description
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Medical records received.After review of medical records, the medical records indicate that patient had a left hip revision on (b)(6) 2017 due to septic arthritis.It is unknown if any depuy implants were implanted at this time.
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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.Through follow up it is now understood there is no allegation associated against a product malfunction.Review of the x-ray evidence found nothing indicative of a device nonconformance.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
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Search Alerts/Recalls
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