Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Naturally Worn (2988)
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Patient Problems
Adhesion(s) (1695); Cyst(s) (1800); Fatigue (1849); Foreign Body Reaction (1868); Hematoma (1884); Hypersensitivity/Allergic reaction (1907); Muscular Rigidity (1968); Nerve Damage (1979); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Balance Problems (4401); Joint Laxity (4526); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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Event Date 06/14/2022 |
Event Type
Injury
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Event Description
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Mom pinnacle litigation record received.Patient alleges elevated metal ion, patient alleges injury to muscle and tissue, suffered additional scar tissue formation, and now has a hip replacement with decreased longevity.As a direct and proximate result, patient suffered pain, injury caused by metallosis, metal wear, metal poisoning, loss of enjoyment of life, limitation of daily activities, economic loss, emotional trauma and distress, mental anguish, immobility, permanent instability and loss of balance, and physical disability.Doi: (b)(6) 2009.Dor: (b)(6) 2022.(unk hip).
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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.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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese joint reconstruction, or its employees caused or contributed to the potential event described in this report.Unspecified tissue injury (e2015) is being utilized to capture bone injury & soft tissue injury.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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After review of the medical records, the patient was revised to address right hip pain, periprosthetic osteolysis, metallosis, greater trochanter fracture, osteolysis in acetabulum and femur, pseudotumors, and neurolysis.Operative note reported trochanter fracture and pseudotumor.There was a very thick gelatinous material.This was dark in appearance and filled the entire hip capsule.Excised pseudotumor and neurolysis due to proximity of sciatic nerve.The socket posterolateral wall was missing.There was osteolysis in the stem.Procedures done were revision of right tha, excision of pseudotumor, neurolysis, capsulorrhaphy, bone grafting cup and femur, and biopsy for muscle tendon and bone deep.Doi: (b)(6) 2009; dor: (b)(6) 2022; 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 : a manufacturing record evaluation (mre) will not be performed since mom systems are obsolete.
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Event Description
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Medical records received.After review of the medical records, there was no new harm or device-related problem provided.Litigation records allege due to defective design and manufacturing processes plaintiff suffered a fractured trochanter, there was hip soreness, and pain, and unable to get out of bed without assistance the day after.The fractured greater trochanter was confirmed in his x-rays.The litigation alleges periprosthetic osteolysis, metallosis, greater trochanter fracture, and osteolysis in the acetabulum and femur.Plaintiff underwent revision with excision of the pseudotumor, sciatic nerve neurolysis, and bone grafts for both the acetabulum and proximal femur.There was severe bone deterioration that was unable to perform bone grafts.Plaintiff developed a large fluid collection around the hip resulting to metallosis, pseudotumor, severe pain, fractured trochanter, and osteolysis.Plaintiff suffered pain, discomfort, walking difficulty, limited adl and emotional distress, and inability to sleep.Plaintiff alleges adverse local tissue reaction and toxic heavy metal however, the lab result reported metal ions are below 7 ppb.
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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).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.H6: unspecified musculoskeletal problem (e1635) is being utilized to capture bone disorder.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.After review documented findings were cyst : fluid collection, capsulorrhaphy, bone grafting ( acetabulum & proximal femur ).Patient underwent left knee arthroplasty however utilizing competitors devices.Implants remained unknown as there were no sticker sheets 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.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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Event Description
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Medical records received.Patient visited the clinic due to stiffness of right hip, difficulty in walking, pain in right hip, unsteadiness on feet, loss of function, swelling, and muscle weakness.Increasing pain from 0/10 to 7/10.Doi: (b)(6) 2009; dor: (b)(6) 2022; right hip.
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Search Alerts/Recalls
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