MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-411
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event; an event regarding instability involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: no product was returned for evaluation however, a photograph was provided.The photograph shows a recently explanted insert.Blood is visible on the insert.Damage is also visible on the insert.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: undated/unlabeled: photo of removed polyethylene with severe posterior wear (med or lat not labeled).(b)(6) 2021: x-ray bilateral ap knees.Left looks oddly positioned fem-tib.(b)(6) 2021: vital signs, bmi 40.41, otherwise stable.Undated operative note: (b)(6) 2016, primary left tka.Morbid obesity bmi 48.58 o woman.End staged djd knee.Prior right tka 12/2013 but had dvt.Good trialing with 11 mm insert.Uncemented size #4 cr femur, tritanium tibia size #4, 11mm cr x3 polyethylene, a32 patella (all-poly-cemented).Confirmation: the event cannot be confirmed.While there is an unlabeled photo of what appeared to be an extracted polyethylene tibial tray, there are no notes, history or documented revision procedures.Root cause: no root cause can be ascribed to the case as the event cannot be confirmed.That said, the pi report reports instability in a morbidly obese patient.The extracted poly showed an abnormal wear pattern with severe wear posteriorly at one of the compartments (med or lat), the knee was unstable rotationally in this posterior plane and subluxating.Device history review: all 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 reported lot.Conclusion: the medical report indicated: the event cannot be confirmed.While there is an unlabeled photo of what appeared to be an extracted polyethylene tibial tray, there are no notes, history or documented revision procedures.Further information such as return of the device, pre- and post-operative x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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.
Event or Problem Description
It was reported that the patient's left knee was revised due to pain and instability.Patient was revised from a 4x11 insert to a 4x16 insert.Rep reported that all available information has been submitted.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 12127880
• Report Number: 0002249697-2021-01151
• Device Sequence Number: 4429118
• Product Code: MBH
• UDI-Device Identifier: 07613327050486
• UDI-Public: 07613327050486
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 5530-G-411
• Device Catalogue Number: 5530-G-411
• Device Lot Number: 5M5259
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 106