Reported event: an event regarding crack/fracture and patient factors (patella tendon rupture) involving a triathlon insert was reported.The patient factors (patella tendon rupture) event was confirmed; the crack/fracture event was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports the complication of a rupture of the patella tendon after total knee arthroplasty.How soon after surgery is unclear due to discrepancies noted above.I can confirm that this event took place since i was able to view the pre-op and post-op radiographs and the index and revision operation report.However, no patient identifier is on the operation reports because they were redacted.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of patella tendon rupture after total knee replacement are multifactorial including trauma, patient activity factors and possible damage to the tendon at surgery." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient underwent surgery for the repair of a ruptured patella tendon following a slip and fall incident.Intraoperatively, the triathlon insert was revised as it was observed to have a "notch" in it.A review of the provided medical records by a clinical consultant confirmed the patella tendon rupture event but was unable to determine root cause: "this inquiry reports the complication of a rupture of the patella tendon after total knee arthroplasty.[.] i can confirm that this event took place since i was able to view the pre-op and post-op radiographs and the index and revision operation report.[.] regarding the possible root cause of this event, i cannot determine it with certainty.Causes of patella tendon rupture after total knee replacement are multifactorial including trauma, patient activity factors and possible damage to the tendon at surgery." return of the device and/or photographs of the event are required to confirm the reported crack/fracture of the insert.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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