Model Number 320-01-36 |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/11/2019 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.Concomitant medical device(s): reverse tray (cat# 320-10-00 / sn# (b)(4)).Humeral liner (cat# 320-36-13 / sn# (b)(4)).Torque defining screw kit (cat# 320-20-00 / sn# (b)(4)).Reverse tray adapter plate (cat# 320-10-10 / sn# (b)(4)).Torgue defining screw kit (cat# 320-20-00 / sn# (b)(4)).Rev locking screw (cat# 320-15-05 / sn# (b)(4)).Compress lck cap (cat# 320-20-18 / sn# (b)(4)).Compress lck cap (cat# 320-20-26 / sn# (b)(4)).Compress lck cap (cat# 320-20-22 / sn# (b)(4)).Compress lck cap (cat# 320-20-18 / sn# (b)(4)).Compress lck cap (cat# 320-20-30 / sn# (b)(4)).
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Event Description
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It was reported that the patient had gone through a shoulder reverse on the (b)(6) of (b)(6) 2019, due to baseplate loosening and instability on the glenoid the shoulder was revised.
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Manufacturer Narrative
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Section h10: (h3) the revision reported was likely the result of an insufficient bond between the implant and the bone, patient¿s bone quality, or a combination of the two, which led to aseptic (non-infected) loosening of the glenoid baseplate and instability.However, this cannot be confirmed as the devices were not available for evaluation.(h4) device manufacture date: 08-feb-2019.
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Manufacturer Narrative
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Section h10: (g5) pma/510(k)number: k063569.Section h11: *the following sections have corrected information: (d4) catalog number: 320-15-01, serial number: (b)(6), expiration date: 05-feb-2029, unique identifier (udi) #: (b)(4).(d11) concomitant device(s): ** added glenosphere** 36mm glenosphere (cat# 320-01-36 / sn#: b)(6)).Reverse tray (cat# 320-10-00 / sn#: b)(6)).Humeral liner (cat# 320-36-13 / sn#: b)(6)).Torque defining screw kit (cat# 320-20-00 / sn#: b)(6)).Reverse tray adapter plate (cat# 320-10-10 / sn#: b)(6)).Torgue defining screw kit (cat# 320-20-00 / sn#: b)(6)).Rev locking screw (cat# 320-15-05 / sn#: b)(6)).Compress lck cap (cat# 320-20-18 / sn#: b)(6)).Compress lck cap (cat# 320-20-26 / sn#: b)(6)).Compress lck cap (cat# 320-20-22 / sn#: b)(6)).Compress lck cap (cat# 320-20-18 / sn#: b)(6)).Compress lck cap (cat# 320-20-30 / sn#: b)(6)).
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Search Alerts/Recalls
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