Catalog Number 136536320 |
Device Problems
Material Disintegration (1177); Metal Shedding Debris (1804)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Discomfort (2330)
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Event Date 01/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 record received.Litigation record alleges friction and wear, large amounts of toxic cobalt and chromium metal ions, pain, discomfort, functional difficulties and elevated metal levels.Doi: (b)(6) 2005; dor: not reported; left hip (pinnacle).
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Manufacturer Narrative
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(b)(4).No device associated with this report was received for examination.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).
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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.
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Event Description
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Update ad 7 aug 2018: (b)(4) has been re-opened due to the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges infection requiring antibiotics, pseudotumor, abductor muscle repair, and metallosis.Doi: (b)(6) 2005 ¿ dor: none reported (left hip).
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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.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 will be filed as appropriate.
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Search Alerts/Recalls
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