DEPUY ORTHOPAEDICS INC US S-ROM*STM STD,36NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM
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Model Number 52-3193 |
Device Problem
Degraded (1153)
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Patient Problems
Erosion (1750); Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Swelling (2091); Synovitis (2094); No Code Available (3191)
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Event Date 02/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.(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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Pinnacle medical record received.After review of medical record, patient was revised to address pain and synovitis.Revision notes stated that a bulging thickened hip capsule was noted.A 10cc of dark red particulate fluid was removed from the joint and dark red brown effusion was evacuated.The head and liner were removed.There was moderate amount of trunnionosis and corrosion of the femoral trunnion.Operative findings noted metallosis with mark effusion, large pseudotumor, and osteolysis.Blood cobalt levels were increasing but less than 7 ppb.Clinic visits noted erosions of proximal femur.Doi: (b)(6) 2006 - dor: (b)(6) 2020 (left 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.H10 additional narrative: added: d11.Corrected: e1, e2, e3.E3 initial reporter occupation: lawyer.A follow up will be conducted to provide the legal plaintiff information in section e for the initial reporter once the details are provided.
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