ZIMMER BIOMET, INC. PERSONA REVISION VIVACIT-E CCK ARTICULAR SURFACE LEFT 14MM WITH LOCKING SCREW; PROSTHESIS, KNEE
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Model Number N/A |
Device Problems
Unstable (1667); Noise, Audible (3273); Migration (4003)
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Patient Problem
Pain (1994)
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Event Date 04/27/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10 - concomitant devices - persona revision cemented femoral component plus size 9+ left catalog #: 42504606611 lot #: 64463034, persona offset splined uncemented stem extension 3mm x 16mm catalog #: 42560313516 lot #: 64523184, persona revision femoral cemented distal augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64416178, persona revision femoral cemented distal augment size 9, 9+ 5mm catalog #: 42556606605 lot #: 64362194, persona revision cemented tibial tray left size d catalog #: 42542006701 lot #: 64334561, persona offset splined uncemented stem extension 3mm x 14mm catalog #: 42560313514 lot #: 64573160, persona tibial cone catalog #: 42545000508 lot #: 64154173, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 848aad1612, persona tibial cone catalog #: 42545000508 lot #: 64154173, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 838baf1806, refobacin bone cement r 1x40 us catalog #: 110034355 lot #: 838baf1806 the complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.
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Event Description
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It was reported that the patient is being considered for a left knee arthroplasty revision to address pain, stiffness and instability as a result of the articular surface locking screw backing out approximately three (3) years post-operatively.The revision is unable to be performed at this time due to the patient's availability, however, the revision will be planned once the patient is able to do so.Initial operative notes noted no intraoperative complications.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, b6, g3, g6, h2, h6, h10.
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Event Description
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It was reported that the patient is being considered for a left knee arthroplasty revision to address pain, stiffness, instability and implant noise as a result of the articular surface locking screw backing out approximately three (3) years post-operatively.The patient is being scheduled for a revision when available.Initial operative notes noted no intraoperative complications.
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