Catalog Number 101211150 |
Device Problems
Degraded (1153); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Tissue Damage (2104); No Code Available (3191); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/14/2016 |
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.(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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The patient was revised to address unknown reasons.Update 01/20/2017 claim letter and medical records received.After review of the medical records for mdr reportability, litigation alleges hip pain, elevated metal ion toxicity, soft tissue damage and an overall decline in health.Also alleges within the right hip, the presence of significant fluid collection and soft tissue injury by way of mri--but surgeon noted mri report indicated "no evidence of significant soft tissue injury or pseudotumor".Revising surgeon indicated, in office note on (b)(6) 2016, that metal ions are markedly elevated, with chromium 24 and cobalt 45 (no units reported).In the revision operative note, surgeon identified "black and darkened synovial tissue and avascular tissue consistent with metallosis".Also noted "corrosion.At the femoral head." also noted "that the acetabular component was.In slightly increased anteversion and abduction", and was revised.Pain, metallosis, elevated metal ions, corrosion, and malpositioned implant harms added to complaint.Stem is added to complaint (part/lot from invoice).The complaint was updated on: 1/27/2017.
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Manufacturer Narrative
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No device associated with this report was received for examination.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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Manufacturer Narrative
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Depuy still 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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Event Description
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Update (4/5/2017) - legal submission received.After review of this submission, there is no new information that would change the existing mdr decision.
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Manufacturer Narrative
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(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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Manufacturer Narrative
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(b)(4).
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Event Description
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Ppf alleges metal wear/metallosis and elevated metal ions.
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Event Description
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Pfs alleges injuries, pain right hip, elevated metal ions, mri showed significant fluid collection and soft tissue injury and limited adl.Patient had sustained a permanent damage due to elevated metal ions in the system.After the first revision, there was continued chronic pain in the groin, hip and radiated to buttock and back.Ppf alleges metal wear, metallosis and elevated metal ions confirmed in the medical records.After review of the medical records, the patient was revised to address failed mom right tha resulting to pain, elevated metal ions and limited adl.Operative notes reported that the patient had black and darkened synovial tissue and avascular tissue consistent with metallosis.There was corrosion noted at the femoral head.Stem was well fixed.Acetabular was noted to have slightly increase anteversion and abduction and this was removed without difficulty.Right hip pericapsular tissue or pseudotumor.Doi: (b)(6) 2006 and 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.Udi (b)(4).H6 clinical code)appropriate term / code not available (e2402) is used to capture blood heavy metal increased.
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Search Alerts/Recalls
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