Model Number 1218-87-354 |
Device Problems
Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994); Distress (2329); Discomfort (2330); Osteolysis (2377); Ambulation Difficulties (2544); Test Result (2695); No Code Available (3191); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/26/2020 |
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.
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Event Description
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It was reported that the patient brought to or for removal of metal liner and metal head.Patient had pain and high metal ion levels.Observed presence of pseudo tumor due to metalosis.Doi: unknown, dor: unknown, affected side: 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 provided x-ray image has been reviewed and the reported allegations could not be confirmed.The root cause could not be determined.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.
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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: corrected: b4, g1 (physical manufacturer).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 provided x-ray image has been reviewed and the reported allegations could not be confirmed.The root cause could not be determined.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.E3 initial reporter occupation: lawyer.
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Event Description
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In addition to what were previously alleged, records alleges discomfort and walking difficulty.Doi: (b)(6) 2008 dor: (b)(6) 2020.Right hip.
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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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After review of medical record, patient was revised to address adverse tissue reaction associated with metal-on-metal articulation.Revision notes stated that a 20ml brownish fluid was aspirated.There was a friable brownish tissue that encapsulated the right hip joint.There was blackening of the trunnion, but no signs of pitting or significant corrosion at the trunnion.Head and liner were removed.Fibrous tissue with chronic inflammation, histiocytosis, and fibrin was noted in specimen examination.
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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 provided x-ray image has been reviewed and the reported allegations could not be confirmed.The root cause could not be determined.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 complaint database search and/or manufacturing record evaluation (mre) will not be performed.H6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the bone injury and metal poisoning.
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Event Description
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Litigation alleges heavy metal poisoning form toxic heavy metals released by the implant causing injury, pain, permanent destruction, irrigation and debridement of brown fluid and tissue, metal wear, adverse tissue reaction, emotional trauma and distress.
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Manufacturer Narrative
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Product complaint # (b)(4).Investigation summary : update 17-sep-2021.No device associated with this report was received for examination.The provided x-ray image has been reviewed and the reported allegations could not be confirmed.The root cause could not be determined.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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In addition to what was previously reported, clinical visit reported trochanteric bursitis of hip, pseudotumor from mom replacement.Mri showed osteolysis at the greater trochanter, adverse local tissue reaction, distention of the right hip pseudo capsule with mixed solid and fluid.Doi: on (b)(6) 2008.Dor: on (b)(6) 2020.Right hip.
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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, b1, b5, b7, d4 (expiration date), h6 (clinical code).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.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 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.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.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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