STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ6 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5512-F-601 |
Device Problem
Material Deformation (2976)
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Patient Problems
Cyst(s) (1800); Injury (2348); Inadequate Osseointegration (2646); Fibrosis (3167)
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Event Date 05/14/2012 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.
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Event Description
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Letter received from patient's lawyers advising the stryker ts triathlon knee replacement is "defective and materially contributed to.On going left lower limb problems including the development of a pseudo-tumour".Patient is reports left knee problems following surgery on the (b)(6) 2012.Please see communication log for details regarding additional information.As per op report: comments: triathlon ts cemented revision knee from (b)(6) year old male revised after 4 years due to osteolysis and alval (pseudotumour) is presented for analysis.High activity level and medial bone loss around the tibial component are considered contributory factor to failure of the device.Femoral component: a combination of bone and fibrous tissue onto cement mantle indicating a well fixed components - numerous longitudinal scratches on bearing surface.Threaded boss covered with organic material and showing wear on the surface in contact with stem extender (fig.1).Femoral stem extender: corrosion and wear in the base of threaded trunnion from uneven engagement with femoral component boss covered with organic material (fig.2).Femoral stem: wear in the base of threaded trunnion from uneven engagement with femoral.Extender tibia baseplate: polished cement surface, indicative of micromotion, postero-medially.Bone tissue still attached to the cement mantle, anteriorly.Severe fretting corrosion of the surface of the boss as well as corrosion deposits in the threaded boss in contact with stem trunnion.Tibial stem: component was loose and removed from the baseplate manually.Gross fretting and corrosion in the trunnion: stem surface (inset, fig.4), and in the trunnion threads (fig.5) polyethylene (pe) insert: slight wear on the bearing surface, mostly scratching and burnishing.Burnishing around the ps post, posteriorly and media-lateral regions from contact with the femoral component.
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Search Alerts/Recalls
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