DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX20MM; BONE SCREWS AND PINS : SCREWS
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Catalog Number 121720500 |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Tissue Damage (2104); Inadequate Osseointegration (2646); No Code Available (3191)
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Event Date 03/31/2014 |
Event Type
Injury
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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.Initial reporter occupation: non-healthcare professional ¿ attorney (b)(4).
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Event Description
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Complaint description: patient was revised to address pain.Litigation alleges the patient suffers from metal poisoning.Pfs alleges clicking.After review of the medical records for mdr reportability, the revision operative note indicated pain, metallosis/metal debris, increased metal ions (no labs provided), and malpositioned cup.The cup wasn't revised.There was no mention of any clicking as pfs alleged.Ppf alleges loosening of cup and fracture (component).Added screws due to alleged loosening and unknown hip implant because of fracture (component).Doi: (b)(6) 2007 - dor: (b)(6) 2014 (right 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.Device history lot = > bt9aj4000.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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