Model Number 1521-90-059 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Hypersensitivity/Allergic reaction (1907); Renal Failure (2041); Joint Dislocation (2374); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 01/01/2021 |
Event Type
malfunction
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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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This pc is related to (b)(4).This pc reports about the second dislocation and osteolysis.It was reported that on an unknown date, 1991, the patient underwent the tha surgery with unknown cup and stem.After the surgery, on an unknown date, the loosening of the cup and stem occurred, and the first revision surgery was performed on (b)(6) 2010.After the surgery, the patient dislocated on an unknown date, 2016.The surgeon commented that ct can show widespread tumorous appearance around the hip.Osteolysis can also be confirmed.It may be a pseudotumor symptom due to cobalt chromium.Currently, reoperation is postponed due to decreased renal function.On an unknown date 2021, the patient dislocated again and x-ray showed osteolysis of the pelvis and femur.The second revision surgery will be performed if necessary and the liner and cup will be replaced.No further information is available.
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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.Visual examination of the provided x-ray images confirmed the reported dislocation.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.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.Device history lot : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.
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Search Alerts/Recalls
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