STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5531-G-211 |
Device Problems
Loss of Osseointegration (2408); Noise, Audible (3273)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 03/01/2023 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
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Event Description
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Patient reported joint loosening and audible noise following primary triathlon left knee surgery.Patient stated that symptoms started "immediately" following the (b)(6) 2020 surgery and that the knee was "never good".Patient stated she feels the loosening and did not state whether her surgeon confirmed the loosening.Patient stated that the joint noise is heard when she moves her "toes up and down".
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Event Description
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Patient reported joint loosening and audible noise following primary triathlon left knee surgery.Patient stated that symptoms started "immediately" following the february 2020 surgery and that the knee was"never good".Patient stated she feels the loosening and did not state whether her surgeon confirmed the loosening.Patient stated that the joint noise is heard when she moves her "toes up and down".
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Manufacturer Narrative
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An event regarding femoral loosening involving a triathlon insert was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.During revision surgery, it is considered good surgical practice to always replace bearing components such as the tibial insert or hip liner including femoral head with new devices, also because service life damage or wear is not always readily visible and these components are usually modular and removal is easy and straightforward.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Patient would like to know if her implants were involved in a recall.It was confirmed that this device was not recalled.
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Search Alerts/Recalls
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