DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN DEPUY PINNACLE METAL INSERT 36 MM X 52 MM; PINNACLE MTL INS NEUT36IDX54OD
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Catalog Number 121887354 |
Device Problems
Corroded (1131); Material Disintegration (1177); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)
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Patient Problems
Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Muscle Spasm(s) (1966); Pain (1994); Discomfort (2330); Limited Mobility Of The Implanted Joint (2671)
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Event Date 08/10/2016 |
Event Type
malfunction
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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.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.
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Event Description
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Oct 24, 2017: litigation received.Litigation alleges pain and elevated metal ion levels in the blood.Revision reported metallosis and pseudotumor, described as blackened pseudotumor present along the posterior capsule that extend up into the region of the abductors and trochanteric bursa and corrosion on the taper of the femoral component.This complaint was updated on oct 31, 2017.
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Manufacturer Narrative
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No device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.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 was previously litigated, patient also alleges right groin discomfort, developed numbness in her legs, spasms, decreased range of motion.Patient continues to experience muscle tightness, pain and intermittent muscle spasm.After review of medical records for mdr reportability it was reported that the patient was revised to address metallosis and pseudotumor.The patient has developed elevated cobalt and chromium levels.An mri examination shows pseudotumors around both hips.Revision note reported cloudy fluid in the joint.There was some blackened pseudotumor present along the posterior capsule that extended up into the region of the abductors and trochanteric bursa.There was some corrosion on the taper of the femoral component.
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Manufacturer Narrative
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(b)(4).
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Event Description
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In addition to what previously alleged, ppf alleges metal wear.Doi: (b)(6), 2008 - dor: (b)(6), 2016 (left hip).
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Manufacturer Narrative
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(b)(4).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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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, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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