DEPUY ORTHOPAEDICS, INC. 1818910 SUMMIT DUOFIX TAP SZ4 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM
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Model Number 1570-12-100 |
Device Problems
Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Fatigue (1849); Foreign Body Reaction (1868); Headache (1880); Hearing Impairment (1881); Hypersensitivity/Allergic reaction (1907); Pain (1994); Rash (2033); Seizures (2063); Tissue Damage (2104); Burning Sensation (2146); Cramp(s) (2193); Dizziness (2194); Injury (2348); Hypoesthesia (2352); Depression (2361); Shaking/Tremors (2515); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); Test Result (2695); No Code Available (3191)
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Event Date 10/28/2011 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).(b)(6).
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Event Description
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Litigation papers allege: the patient's hips are defective and have caused damage to her hip joints and her body.Update: 10/25/2012 pfs was received from legal.Update: ad 02 may 2018 the receipt of ppf and sticker sheets.In addition to what were previously alleged, ppf alleges metallosis, metal wear and elevated metal ions.Added stem alleged elevated metal ions.
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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: the device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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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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.H10 additional narrative: product complaint #(b)(4).Investigation summary = > the device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may 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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Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.H10 additional narrative: corrected: h6 (device).
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Event Description
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Pfs and medical records received.Pfs alleges multiple significant and persistent injuries, defective implants, metallosis, noise, loosening, stem twist inside the femur, pain, muscle cramps, tendon pain, difficulty standing, walking, sitting and engaging in basic daily activities, dizziness, severe headache, general malaise, depression, rashes, skin irritations, constant irritability, insomnia, problem with eyesight, hearing, and general cognition, difficulty comprehending even basic information, tracking conversations and remembering or focusing on a particular subject matter, significant heart problems, including left ventricular hypertrophy and cardiomyopathy, tremor, grand mal seizures, increasingly and severely unstable, fatigued, instability, poor balance, fall, injuries to eye, nose, head, fractured wrist, burning, tinging, numbness in extremities, constant and significant confusion, and thoughts of suicide.After review of medical records, no revision notes provided.
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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. udi: (b)(4).Patient code: no code available (3191) used to capture the absence of treatment, blood heavy metal increased, tendon injury, sensory loss, heart problem, balance disorder, and soft tissue injury.
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