By checking the dhrs of the involved components (peg lot# 1616465, baseplate lot# 1715029), no pre-existing anomaly was found on the 55 pegs and 30 baseplates placed on the market with the same lot#s.No other complaints received on these lot#s.We will proceed with further investigation and submit a final mdr once concluded.
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During shoulder revision surgery performed on (b)(6) 2019, while the surgeon was removing the glenosphere from the baseplate with short peg, the baseplate with code 1375.15.610 lot# 1715029 disassociated from the tt peg code 1375.14.661 lot# 1616465, creating a defect in patient's glenoid and causing 45 mins of prolonged surgery time.The surgeon resolved this issue by implanting another tt baseplate with a longer peg.Event happened in usa.The revision surgery was also reported to fda as lima complaint #346/19 (fda ref: 3008021110-2019-00128).
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