Model Number 1365-22-000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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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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Consumer claim letter received.There is a problem with metal on poly hip replacement system.The patient experienced pain, severe anemia due to cobalt metal poisoning with cobalt levels reaching 9.7 and chromium reaching 1.2 (no units of measurement provided.The patient was originally implanted with metal on poly.The patient was revised (b)(6) 2020.The head/liner were revised.Patient stated that after the revision, their cobalt levels dropped and they were cured of their anemia.Doi: (b)(6) 2016.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.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 device manufacturing records have been reviewed.No related deviations or anomalies identified.Device history review = > the device manufacturing records have been reviewed.No related deviations or anomalies identified.H10 additional narrative: added: h6 (clinical codes) h6 health effect - clinical code: appropriate term / code not available (e2402) used to capture the metal poisoning and blood heavy metal increased.
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Search Alerts/Recalls
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