Model Number 1365-36-310 |
Device Problems
Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
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Patient Problems
Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Injury (2348); Not Applicable (3189); No Code Available (3191)
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Event Date 02/29/2016 |
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.
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Event Description
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Complaint description: patient was revised to address poly wear due to being noncompliant.The acetabular cup was also noted to have been worn.
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Event Description
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Pinnacle pfs and medical records received.Pfs alleges injury and pain in the lower back.After review of medical records for mdr reportability, the patient was revised due to abnormal polywear and squeaking of the hip.Revision notes reported worn and fractured poly liner, ceramic head was articulating on the metal of the acetabular shell, metal staining in the joint and soft tissues, and large fluid collection of metal-staining dark fluid.There were no lab results provided.Doi: (b)(4) 2015; dor: (b)(6) 2016; 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.
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Search Alerts/Recalls
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