Catalog Number L20312 |
Device Problems
Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Bone Fracture(s) (1870); Pain (1994); Discomfort (2330); Inadequate Osseointegration (2646)
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Event Date 01/13/2017 |
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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Update ad 26 jan 2018: pinnacle litigation record received.Litigation alleges pain, discomfort, and abnormally high levels of cobalt and chromium.Litigation stated that there is a right hip revision on (b)(6) 2017 , however it did not mention that the patient is bilateral.Shall there be new information received, this complaint will be updated and another complaint will be created as necessary.Doi: (b)(6) 2009 -dor: not reported (left hip).
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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 ppf and implant sticker received.Ppf alleges bone fracture, loosening of stem, metal wear and metallosis confirmed in medical records.Ppf stated that the liner , head and stem was the only revised products.Doi: (b)(6) 2009; 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.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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