Catalog Number UNK HIP FEMORAL HEAD METAL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ossification (1428); Abscess (1690); Anemia (1706); Endocarditis (1834); Fatigue (1849); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Discomfort (2330); Ambulation Difficulties (2544); Unspecified Mental, Emotional or Behavioural Problem (4430); Embolism/Embolus (4438); Renal Impairment (4499); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Swelling/ Edema (4577)
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Event Date 01/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.The device catalog number is unknown; therefore, udi is unavailable.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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Unf and pinnacle mom medical records received.After review of the medical records the patient was revised to address hip pain, septic shock, mrsa resistant left hip joint, increase crp, 6 weeks high grade mrsa bacteremia with septic prosthetic and splenic abscess secondary to septic emboli, developed endocarditis, dress, kidney failure, anemia, weakness, walking difficulty, metallosis, necrosis, inflammation and infected left hip.Irrigation and debridement on (b)(6) 2022 due to painful left hip.Operative note reported thick trochanteric bursa, big mass og scar, purulent fluid mixed with metallosis and synovitis.Clinical diagnosis is sepsis of the hip.Acute and chronic inflammation and necrosis.Second irrigation and debridement on (b)(6) 2022 due to infected left hip and hematogenously seated from endocarditis.Operative note reported turbid fluid left hip intracapsular and soft tissues, endocarditis with vegetation on the aorta were encountered, large amount of pus and metallosis tissue in the left hip area.There was an increased in crp and white blood cells.Doi: (b)(6) 2007, doe: (b)(6) 2022 irrigation and debridement left hip, doe: (b)(6) 2022 irrigation and debridement left hip, dor:unrevised.
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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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Patient claim letter alleges pain, limited adl, delirium, elevated metal ion, metallosis, septic shock, necrosis, infection, mrsa, acute and chronic inflammation, increase crp, splenic abscess and septic emboli.The patient developed endocarditis, dress syndrome, kidneys failure, anemia, weight bearing, weakness and walking difficulty.Patient suffered six weeks hospitalization, 2 debridement surgeries, 6 weeks iv medication, endocarditis, renal failure and drug reaction with dress syndrome, kidney damage and thyroid and infection.After review of the medical records, clinic visit and operative note on irrigation and debridement reported pain, discomfort, limited range of motion, infection, developed endocarditis, renal failure and drug reaction with dress syndrome, kidney and thyroid damage.Fist i and d due to sepsis and with acute and chronic inflammation and necrosis.Second i and d is due to recurrent infection and encountered endocarditis.There is no indication of revision in this medical record since patient is hesitant due to possible more serious complication.However, revision is possible in the near future.Patient is seeking settlement for the damages and injuries experience.Doi: (b)(6) 2007, dor: unrevised, left hip (mom).
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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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After review of the medical records, clinical visit reported pseudotumor formation, effusion and bursitis.There is moderate to severe narrowing of left ischio-femoral interval secondary to heterotopic ossification medial to the femur.Susceptibility artifacts arising from the metallic hardware limits visualization of surrounding structure in bilateral hip.Likely causing impingement of the quadratus femoris muscle.Mild tendinosis of left hamstring tendon these are from mri findings on (b)(6) 2021.There were no information pertaining to the right hip implants if depuy products were involved.
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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 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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Search Alerts/Recalls
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