DEPUY ORTHOPAEDICS, INC. 1818910 ASPHERE M SPEC 12/14 40 +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
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Catalog Number 136505100 |
Device Problems
Material Disintegration (1177); Naturally Worn (2988)
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Patient Problems
Host-Tissue Reaction (1297); Pain (1994); Discomfort (2330); Injury (2348); Deformity/ Disfigurement (2360); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); Not Applicable (3189); No Code Available (3191)
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Event Date 04/25/2018 |
Event Type
Injury
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Manufacturer Narrative
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(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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Litigation alleges friction and wear between the metal head and liner caused the release of toxic metal ions and particles into the patient's body resulting to injury, discomfort, soreness, disfigurement, mental anguish, suffering, emotional distress and inability to perform normal daily activities.Also, it was reported the cup was loose.
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Manufacturer Narrative
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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.(b)(4)2018 additional information and new allegations received.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, a follow-up medwatch will be filed as appropriate. .
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Additional narrative: corrected:evaluation codes (device codes).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 : 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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Event Description
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Ppf alleges metallosis and pseudotumor.Added expiration date and dob.Updated stem details.Added 2 screws to the complaint.
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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. udi: (b)(4).Added: age or date of birth, event, (expiration date) and (patient code).
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