Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Fall (1848); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/06/2015 |
Event Type
Injury
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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.Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Event Description
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Complaint description: patient has experienced a possible allergic reaction, pain and stem and cup loosening.Revision implant date (b)(6) 2014.Update rec'd 14 may, 2015 - the patient's medical records were received.Medical records were reviewed for mdr reportability.There is no new information that would change the existing mdr decision.The complaint was updated on: (b)(6) 2015.
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Search Alerts/Recalls
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