STRYKER ORTHOPAEDICS-MAHWAH NO 3. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5537-G-311 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: device name: triathlon asymmetric x3 patella; cat#:5551-g-320; lot#:5j5p.Device name: tri ts femur sz3 right; cat#: 5512-f-302; lot#: kwtt.Device name: tri cemented stem 12mmx50mm; cat#: 5560-s-112; lot#: 0044154l.Device name: tri ts baseplate size 3; cat#:5521-b-300; lot#: veyda.Device name: tri cemented stem 12mmx50mm; cat#: 5560-s-112; lot#: 0044804l.Device name: triathlon total knee system offset adapter 4mm; cat#: 5570-s-040; lot#: 0036345a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
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Event Description
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This pi is for the revision of the patient's right knee on (b)(6) 2020.In reporting a revision of the patient's right knee on (b)(6) 2020, the rep provided a revision implant sheet from (b)(6) 2020 for a poly swap which was performed due to infection.A 3x11 ts insert was exchanged for another 3x11 ts insert.
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Search Alerts/Recalls
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