(b)(4).Concomitant medical products: 650-0871, 32mm cocr biomet fem hd -3 nk, 1806301; 22-300919, arcos 19x190mm spl tpr dist ha, 729090; 22-301300, arcos con sz a std 50mm ha, 633150; ep-105833, epoly rlc 32mm 10deg sz23, 220060; unknown hip shell; 350806, 2.0 mm ss cable/sleeve combo, 300410.(b)(6).The complaint cannot be confirmed as the follow op notes were not provided.X-rays were reviewed; overall fit and alignment of the implants is appropriate.Osteopenia is present on all images.X-ray demonstrates lucency along the proximal femoral component which can suggest early loosening.Oblique fracture of the proximal femoral diaphysis laterally is also seen on this image which could mean the periprosthetic fracture sustained causing the revision never healed.This, however, is unconfirmed.The device history records cannot be reviewed as the product information is limited.Root cause could not be determined with information available.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 01363; 0001825034 - 2018 - 01364; 0001825034 - 2018 - 01366; 0001825034 - 2018 - 01367; 0001825034 - 2018 - 08730.
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It was reported in a clinical study that a patient underwent right hip revision surgery following a periprosthetic fracture, and subsequently, the patient reported moderate pain and inability to perform usual activities at a follow up visit approximately two years post operatively.No additional information is available.
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