STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #5 PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
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Catalog Number 6020-0537 |
Device Problems
Corroded (1131); Degraded (1153); Disassembly (1168)
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Patient Problems
Injury (2348); Osteolysis (2377); Reaction (2414)
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Event Date 05/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.
Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts.
Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery.
Not returned.
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Event Description
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It was reported that on (b)(6) 2018, dr.
(b)(6) performed a revision of an accolade stem with a dislocated femoral head component as visible by preop x-ray.
Update per med review: cup malposition in near absent anteversion has contributed to an overload condition in the arthroplasty, especially near the trunnion section causing secondary corrosion between femoral head and stem taper leading to progressive metal substance loss with metallosis in the joint space, loss of taper lock and ultimately disassociation between stem trunnion and femoral head requiring revision.
Additionally, there is osteolysis around the proximal stem section although the stem remains well fixed in the more distal parts.
Also around the cup is osteolysis evident, especially around the supplemental screw fixation although also the cup still appears stable in the bone near the periphery.
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Search Alerts/Recalls
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