Catalog Number 101201100 |
Device Problem
Malposition of Device (2616)
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Patient Problems
Edema (1820); Pain (1994); Tissue Damage (2104); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 04/05/2010 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Litigation alleges that patient suffered from severe pain and discomfort in his left hip.The pain has been continuous and has significantly interfered with his normal daily activities.Doi: (b)(6) 2006 - dor: (b)(6) 2010 (right hip).Part/lot information was identified.Records are available if needed for further review.Medical records confirm the product placement in the right hip.Update ad 20 jun 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf and sticker sheets record.Ppf has no new allegation.Added facility name, lawyer, products expiration and udi.Doi: (b)(6) 2006 - dor: (b)(6) 2010 (right hip).Patient is bilateral, please see (b)(4) for the 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.
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Search Alerts/Recalls
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