Model Number 1012-04-080 |
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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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).Initial reporter 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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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
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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.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : the lot cx2ht1000 does not reflect a valid finished goods lot number.Therefore, a manufacturing records evaluation (mre) was not performed as no valid finished goods lot number was provided for this device 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: 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 (101204080/cx2ht1) product and lot numbers, and no non-conformances were identified.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.
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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 ((b)(4).) product and lot numbers, and no non-conformances were identified.Device history review = > a manufacturing record evaluation was performed for the finished device ((b)(4).) product and lot numbers, and no non-conformances were identified.
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Search Alerts/Recalls
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