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Catalog Number 113653 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994)
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Event Date 08/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant products: versa-dial/comp ti std taper cat# 118001 lot# 168410; comp rvrs shldr glnsp std 41mm cat# 115320 lot# 397490; acrom xl 44-41 std hmrl brng cat# xl-115366 lot# 742400; comp rvs hmrl ti tray 44mm cat# 115340 lot# 988750; comp rvs cntrl scr 6.5x45mm st cat# 115385 lot# 683180; comp non-lckng screw 4.75x40mm cat# 180512 lot# 919380; comp non-lckng screw 4.75x40mm cat# 180512 lot# 490220; comp locking screw 4.75x25mm cat# 180502 lot# 719990; comp locking screw 4.75x25mm cat# 180502 lot# 719990; comp locking screw 4.75x30mm cat# 180503 lot# 003710; comp non-lckng screw 4.75x35mm cat# 180511 lot# 064300.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 00306, 0001825034 - 2022 - 00307, 0001825034 - 2022 - 00308, 0001825034 - 2022 - 00309, 0001825034 - 2022 - 00310, 0001825034 - 2022 - 00311, 0001825034 - 2022 - 00312, 0001825034 - 2022 - 00313, 0001825034 - 2022 - 00314, 0001825034 - 2022 - 00315, 0001825034 - 2022 - 00316.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 7.5 years postimplantation due to pain.During the revision, metal debris was noted, the well fixed stem was explanted, and a proximal humeral fracture occurred and repaired.All components were exchanged without complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Manufacturer Narrative
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Upon reassessment of the reported event, this report should be voided as it was determined to be a duplicate complaint.Event will be captured under mfr number: 0001825034 - 2022 - 00452, 0001825034 - 2022 - 00453 , 0001825034 - 2022 - 00454, 0001825034 - 2022 - 00455, 0001825034 - 2019 - 05285-3, 0001825034 - 2022 - 00456, 0001825034 - 2022 - 00457, 0001825034 - 2022 - 00458, 0001825034 - 2022 - 00459, 0001825034 - 2022 - 00460, 0001825034 - 2022 - 00461, 0001825034 - 2022 - 00462.
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Search Alerts/Recalls
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