Model Number 1365-04-000 |
Device Problems
Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Adhesion(s) (1695); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Depression (2361); Osteolysis (2377); Ambulation Difficulties (2544); Fibrosis (3167); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 02/09/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Occupation: lawyer.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.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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Pinnacle mom litigation records received.Litigation alleges heavy metal poisoning due to elevated metal ions resulting to injury to the muscles, tissues, metallosis, scar tissue formation, limited adl, emotional trauma, distress and pain.Doi: (b)(6) 2009, dor: (b)(6) 2022, hip unknown.
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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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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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.H6 clinical codes: metal related pathology (e1618) is used to capture metal poisoning and blood heavy metal increased.Unspecified tissue injury (e2015) is used to capture bone injury and soft tissue injury.
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Event Description
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After review of medical record, patient was revised to address pain, metal on metal reaction with pseudotumor.Patient had elevated metal ion.Revision notes stated that he had a large effusion within the joint.He was noted to have corrosion at the stem head junction by the trunnion.We then debrided the anterior fibrous tissue fibrous tissue extended anteriorly toward the pelvic rim large amount of pseudotumor was then removed from the anterior aspect of the joint.The cu was removed with minimal bone loss.Doi: (b)(6) 2009, dor: (b)(6) 2022, affected side: left 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.Update received on 22-mar-2023 did not have any additional details to be added in investigation.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.
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Manufacturer Narrative
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Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: a4, b5, b6, b7, h6 health effect - clinical code.H6: distress (e020203) is being utilized to capture stress & emotional distress.Inflammation (e2326) is being utilized to capture inflammation & bursitis.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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Event Description
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Medical records received.In addition to what was previously reported in medical records after review of the records the patient was revised to address cup had a neutral version compared to the spine and cup removed with minimal bone loss and lysis.Prior to the explantation of the cup noted to have lost much of the anterior wall of the acetabulum.Instability with the existing cup.Clinical visit reported hip pain, walking difficulty, trochanteric bursitis, osteophyte over left greater trochanter, osteophyte formation over acetabulum, joint stiffness, tenderness, positive for depression, bruising, stress and sleep disturbance.Pathology report synovium, pseudotumor, fibrosis, hemosiderin laden macrophages, patchy mild lymphoplasmacystic inflammation and metallosis.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.Visual inspection of the x-ray evidence provided found insufficient evidence to confirm implant corrosion.The reported condition was not confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device (136504000/2874735) product and lot numbers, and no non-conformances were identified.
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Search Alerts/Recalls
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