Intra-op event experienced during a shoulder surgery (conversion from anatomic implant to reverse) performed on (b)(6) 2020.The surgeon attempted to remove the poly part of the tt hybrid cem.Glenoid #s low (product code 1379.59.100, lot# 1906362 - ster.1900156) from the peg but it would not disengage.It was reported that the surgeon was unable to remove the poly part despite following the surgical technique.In order to succeed with the conversion, the surgeon had to break the polyethylene, retaining the hybrid peg in situ and operating the conversion.The revision surgery was registered as complaint # (b)(4) and reported to the fda as mfr 3008021110-2020-00079.Surgery was prolonged of about one hour.The product was implanted on the previous surgery of (b)(6) 2019.Patient is a male, (b)(6).Event happened in (b)(6).
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