DEPUY ORTHOPAEDICS, INC. 1818910 PINNACLE MTL INS NEUT36IDX52OD; HIP ACETABULAR INSERT/LINER
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Catalog Number 121887352 |
Device Problems
Naturally Worn (2988); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Inflammation (1932); Pain (1994); Pocket Erosion (2013); Loss of Range of Motion (2032); Rash (2033); Swelling (2091); Synovitis (2094); Tissue Damage (2104); Visual Impairment (2138); Anxiety (2328); Distress (2329); Injury (2348); Depression (2361); Osteolysis (2377); Limited Mobility Of The Implanted Joint (2671); Fibrosis (3167); Not Applicable (3189); No Information (3190); No Code Available (3191)
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Event Date 03/29/2017 |
Event Type
Injury
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Manufacturer Narrative
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This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
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Event Description
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Patient was revised to address elevated ion levels.
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Manufacturer Narrative
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No device associated with this report was received for examination.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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 litigation records received.Litigation alleges pain, elevated metal ions, metallosis, pseudotumor, physical injury, disability, lack of mobility, emotional distress, anxiety and depression.
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Manufacturer Narrative
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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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Pfs and medical records received.In addition to what were previously alleged, pfs alleges burning in the hip, rashes, vision problems and limited range of motion.It was also being alleged that blood clot from the revision surgery caused the left knee to swell and be very painful for 3 weeks.After review of medical records, the patient was revised to address elevated metal ions, osteolysis, pseudotumor, inflammation and synovitis.Operative notes reported whole area was stained with metallosis, pseudotumor, synovitis and fibrinous material that had been metal stained.Pseudocapsule was eroded.Doi: (b)(6)2010: dor: (b)(6)2017; left hip.
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: null.Device history batch: null.Device history review: null.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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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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