Model Number 1218-87-456 |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Edema (1820); Foreign Body Reaction (1868); Muscular Rigidity (1968); Pain (1994); Weakness (2145); Discomfort (2330); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 12/12/2018 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.(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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Unf and medical records received.After review of medical records, patient alleges of hip pain, low back pain, stiffness, weakness, and swelling.The patient walked with an antalgic gait, has limited range of motion to bilateral hips, and felt discomfort when he walked more than 2 blocks.Patient was revised to address trunnionosis and metallosis.Operative notes stated that all intra-articular scar tissue was removed.The femoral head was removed and the trunion was inspected for signs of damage.Significant scuffing of trunnion and inside of head with some blackening consistent with trunnionosis.Stem was assessed for loosening and was found to be well fixed.Liner was also removed.Cup and screws were stable.Well appearing primary metal on metal bearing was noted and no clear backside wear on cup.Doi: (b)(6) 2008.Dor: (b)(6) 2018 (right 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.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.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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Search Alerts/Recalls
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