Catalog Number 999800754 |
Device Problems
Naturally Worn (2988); Noise, Audible (3273)
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Patient Problems
Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint #: (b)(4).Initial reporter occupation: lawyer.(b)(4).Investigation summary: no device associated with this report was received for examination.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed andthe investigation will be re-opened as necessary.
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Event Description
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Asr xl litigation records received.The patient alleges pain, grinding and clicking, injury, metal debris, pseudotumor, metallosis and elevated metal ions levels.Doi: (b)(6) 2007, dor: (b)(6) 2020, 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.This hip replacement platform was voluntarily recalled from the market and the product codes are now considered inactive.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: previous investigations that have included manufacturing record evaluations (mre) since the asr platform was launched have shown no indication of deviations or anomalies with regard to material, manufacturing or inspection.H10 additional narrative: udi (b)(4).
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Event Description
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After review of medical records patient was revised to addressed osteolysis in the calcar under the caller of the stem.Doi: (b)(6) 2007.Dor: (b)(6) 2020.Right hip.
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Search Alerts/Recalls
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