Model Number 1365-53-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330); Injury (2348); Test Result (2695); No Code Available (3191)
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Event Date 01/05/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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 claim submission form and medical records received.After review of the medical records the patient was revised due to pain, discomfort with elevated metal ions.Operative note reported abundant amount of capsular tissue was excised and some inferior bone.However, there were no lab result provided for the metal ions.Doi: (b)(6) 2006.Dor: (b)(6) 2018; left hip 2nd revision.
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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.
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Search Alerts/Recalls
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