This follow-up report is being filled to relay investigation result.Concomitant medical products:- medical products and therapy date.Detail of product: item # 0104555130, item name sidusâ® stem-free shoulder, humeral anchor, uncemented, l, lot # 2693801.Dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: pain / limited range of motion event description: patient was implanted with sidus implants on (b)(6) 2013 and reported continued pain at 1, 2, and 5 year visits with decreased range of motion and pain review of received data: crf study report is reviewed.No osteolysis, radiolucency, hypertrophy or heterotopic ossification were observed at humerus.On the visit dated (b)(6) 2018 pain and impingement is noted, while range of motion is lower than before.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Conclusion: according the crf report the pain that the patient experienced had stopped 1 year post-op and beginned again according 5 year post-op visit.In the last visit also impingement and lower range of motion were noted.No x-rays or medical notes were received.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.The investigation results did not identify a non-conformance or a complaint out of box (coob).The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
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