STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
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Catalog Number 625-0T-28D |
Device Problems
Degraded (1153); Mechanical Problem (1384)
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Patient Problems
Hematoma (1884); Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
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Event Date 11/13/2012 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding impingement and metallosis involving a ceramic liner was reported.The event was confirmed by medical review.Method & results: product evaluation and results: not performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant concluded: ¿on (b)(6) 2011 her tests were negative for infection and she had no pain at that time.On (b)(6) 2012 she noted "pain for five months.Told hematoma returned".Mri showed "possible metallosis".Physical examination revealed mild pain on rotation of the left hip.X-ray showed good alignment and no wear or loosening bilaterally.The plan was bearing revision.On (b)(6) 2012 a revision of the left total hip arthroplasty to change the liner and head was performed for a diagnosis of painful left total hip arthroplasty." [.] ".At surgery an impingement of the titanium neck on the acetabular rim with metallosis in the joint and anterior cyst "likely due to metallosis" was noted.The bearing was changed to a 32/10° poly and a 32/0 cobalt-chromium head.Uncomplicated surgery was described and the patient was subsequently discharged home on (b)(6) 2012.¿ [¿] ¿no examination of the explanted ceramic-ceramic bearing and no surgical pathology report are available.Metallosis as described from impingement of the neck of the femoral component on the metallic rim of the ceramic acetabular insert was the result of version of either the femoral and/or acetabular components and not related to factors of prosthetic design, manufacturing, or materials.The clinical situation was apparently resolved by changing the bearing to metal-poly components at revision surgery on (b)(6) 2012." product history review: a device history review confirmed all devices accepted into finished goods conformed to specification.Complaint history review: no other events were reported for the lot indicated.Conclusions: the investigation concluded that the metallosis was caused by the impingement between the metallic rim of the ceramic insert on the neck of the femoral component.The clinician indicated that the possible root cause for the version of either the femoral and/or acetabular components, however the x-ray images provided reveal that the images are in nominal position.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.Not returned.
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Event Description
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"on (b)(6) 2012 she noted "pain for five months.Told hematoma returned".Mri showed "possible metallosis".[.] during the left hip revision surgery, "at surgery an impingement of the titanium neck on the acetabular rim with metallosis in the joint and anterior cyst "likely due to metallosis" was noted." update 17-jan-2019: medical review clarified that tritanium neck impinged on the metal rim of the ceramic insert.
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