Literature article entitled "pseudotumor and repeated dislocation after total hip arthroplasty with ceramic-on-metal bearing: a case report" written by yin-qiao du, tao luo, jing-yang sun, hai-yang ma, ming ni, and yong-gang zhou.Published by annals of palliative medicine published online/accepted by publisher 15 jul 2020 was reviewed.The article's purpose was to follow the case of a (b)(6) year-old female who underwent multiple revisions and manual reductions involving ceramic-on-metal hip products.The original primary operation occurred in december 2009 involving a cementless pinnacle cup and s-rom stem.Radiographic and intra-operative images can be found on pages 3 and 4 of the literature article.Depuy products with known adverse event(s): femoral head x 2, femoral stem, femoral cone, acetabular cup, acetabular screws x 2, acetabular liner.Adverse events: first revision with femoral head exchange to address pain, instability, difficulty walking, and noise.Subsequent multiple manual reductions to address dislocations leading to an eventual head, liner, and acetabular screw x 2 revision to address pain, fall, decreased range of motion, pseudotumor, cyst, edema, osteolysis, necrosis, inflammation, bone injury, and liner metal wear as well a placement of a cable system to address a femoral bone fracture.
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Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The x-ray images and device photographs within the journal article have been reviewed.In reviewing the images, it was possible to confirm a dislocation event.Also noted is what appears may be a pseudotumor and fluid within the joint.It is not possible however to confirm product failure regarding the reported allegations.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
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