(b)(4).Panzram b, bertlich i, reiner t, walker t, hagmann s, gotterbarm t (2017) cementless oxford medial unicompartimental knee replacement: an independent series with a 5-year-follow-up.Archives of orthopaedic and trauma surgery, july 2017, volume 137, issue 7, pp 1011¿1017, https://link.Springer.Com/content/pdf/10.1007/s00402-017-2696-9.Pdf report source, foreign - event occurred in (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.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.
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Information received based on review of a journal article, entitled "cementless oxford medial unicompartimental knee replacement: an independent series with a 5-year-follow-up", by panzram, b.Et al.(2017).This complaint refers to the reported revision due to reoperation due to loose cement bodies.It was revised by therapeutic arthroscopy with unknown cemented femoral, tibial and bearing components.
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