Model Number 1217-32-052 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Anemia (1706); Hemorrhage/Bleeding (1888)
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Event Date 01/04/2010 |
Event Type
Injury
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Event Description
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Pc was created to capture the event.On (b)(6) 2010, the patient had a right total hip arthroplasty to address right hip arthritis.Depuy components were used during this procedure, including a ceramic head.Post-surgery, anemia secondary to blood loss was noted.The patient was transfused with 250 cc of cell saver blood intraoperatively and on postoperative day #2, due to low hematocrit and hemoglobin the patient was transfused with 1 unit of autologous blood.Doe: (b)(6) 2010 right hip.Please see (b)(4) right hip (1st revision).(b)(4) left hip (1st revision).
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Manufacturer Narrative
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Product complaint # (b)(4).Initial reporter occupation: lawyer.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 : no device associated with this report was received for examination.There is no specified allegation associated with this product.The symptoms experienced are likely procedure related, not product.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 :there is no allegation associated with this product.A complaint database search and/or device manufacturing (mre) review will not be performed even when lot information is known.
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Search Alerts/Recalls
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