STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5532-G-609-E |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Injury (2348)
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Event Date 07/21/2020 |
Event Type
Injury
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Manufacturer Narrative
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Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.The following devices were also listed in this report: triathlon ps fem component, cemented; 5515-f-502; eyb9ua.Triathlon fix.Peg 2 per pk; 5575x000; e479j.Triathlon prim tib baseplate - cemented; 5520-b-600; eav9ba.Triathlon asymmetric x3 patella; 5551-g-350-e; w876.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device not returned.
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Event Description
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It was reported that the patient's right knee was revised due to infection.All devices were removed and a spacer was placed.Rep provided usage sheets from prior surgeries and confirmed that no further information will be released.
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Search Alerts/Recalls
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