(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6.No products were returned to the post market surveillance team for examination.However, two images showing the reported product and confirming the reported event of pin fracture have been received.The connection pin of the distal part of the revitan stem has fractured in the non-blasted area.One image shows the fracture surfaces of both the distal and proximal parts.Macroscopically, as far as visible, no defects that could have triggered or favored the fracture were found on the fracture surfaces.The seating surface as well as the fracture surface of the distal part however does show some polished surfaces, which could have occurred after the fracture.On the other image provided, no bone-ongrowth is evident on the proximal part.There appears to be some indication of bone on-growth and/or scratches and nicks on the distal part.However, due to the quality of the image, no clear judgement can be made.No femoral head is mounted on the proximal part of the revitan stem.A review of the device manufacturing records could not be performed due to missing lot number.A review of the complaint history could not be performed due to missing reference and lot numbers.Due to the lack of available information, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : no product information available.
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