Catalog Number UNK HIP FEMORAL HEAD |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Fatigue (1849); Unspecified Infection (1930); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Weakness (2145); Discomfort (2330); Injury (2348); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
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Event Date 08/25/2017 |
Event Type
Injury
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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.Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown; udi number is unknown.(b)(4).
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Event Description
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Pinnacle mom litigation records received alleging pain, discomfort, swelling, walking difficulty, fatigue, injury, partial or complete loss of mobility and loss of range of motion.Doi: (b)(6) 2006 - dor: (b)(6) 2017, (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.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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In addition to what were previously alleged, pfs alleges weakness, stiffness, walking difficulty and sleeping difficulty.After review of medical records, it was stated that the patient was revised to address infection.Revision notes reported draining abscesses and abundant heterotopic ossification in the femur.An extended torchanteric osteotomy was done to remove the well-fixed stem; this was then cabled.All depuy devices were removed and was implanted with antibiotic spacers.Pathology results indicated acute inflammation.Metal ion levels were also below 7ppb.The patient was re-implanted on (b)(6) 2017 using depuy prosthesis.
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Manufacturer Narrative
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Product complaint#: (b)(4).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. h10: additional narrative: added: h6 (patient).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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