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-311
Medical Device Problem Codes	Material Erosion (1214); Fracture (1260); Unstable (1667); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Laxity (4526); Insufficient Information (4580)
Date of Event	10/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
The following was reported: knee revision.
Additional Manufacturer Narrative
Reported event: an event regarding instability, wear and crack/fracture involving a triathlon insert was reported.The events of wear and crack/fracture were confirmed via evaluation of the returned device and a review of the provided medical records by a clinical consultant.The event of instability was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn leading to the fracture of the posterior portion.The damage present on the posterior portion was consistent with delamination and material loss due to articulation.The damage on the articulating surface of the insert is consistent with burnishing, scratching, and third body indentations; which are common damage modes of uhmwpe.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.Explantation damage around the locking mechanism from removal from the baseplate is also observed.Dimensional inspection: dimensional inspection was not performed because the device was returned damaged.Functional inspection: functional inspection was not performed because the device was returned damaged.Material analysis: not performed as visual inspection provided no indication that the event was a result of a material integrity issue.If further information becomes available additional testing will be performed.Clinician review: a review of the provided medical information by a clinical consultant indicated: narrative: as described above this patient underwent a primary cementless total knee arthroplasty and subsequently developed instability such that approximately eight years later required revision surgery with a triathlon ts prosthesis.Conclusion of assessment: eight years following a primary total knee arthroplasty, this patient had to be revised for instability.I can confirm that both the primary and revision procedure took place since i was able to review the operation reports and the x-rays.The patient did also exhibit a crack in the polyethylene.I cannot determine the root cause of this event with certainty.The causes of late instability and polyethylene failure are multi-factorial including surgical technique factors, patient factors including bmi and activity level, and implant factors.Failure of the polyethylene can occur when instability puts abnormal stresses on the implant.Hyperflexion of the component may have contributed.The implant removed should be submitted to stryker engineers for examination and analysis.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: the events of wear and crack/fracture were confirmed via evaluation of the returned device and a review of the provided medical records by a clinical consultant.The event of instability was not confirmed.A review of the provided medical records by a clinician concluded; eight years following a primary total knee arthroplasty, this patient had to be revised for instability.I can confirm that both the primary and revision procedure took place since i was able to review the operation reports and the x-rays.The patient did also exhibit a crack in the polyethylene.I cannot determine the root cause of this event with certainty.The causes of late instability and polyethylene failure are multi-factorial including surgical technique factors, patient factors including bmi and activity level, and implant factors.Failure of the polyethylene can occur when instability puts abnormal stresses on the implant.Hyperflexion of the component may have contributed.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.
Event or Problem Description
The following was reported: knee revision.Update: revision due to instability.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16535037
• Report Number: 0002249697-2023-00248
• Device Sequence Number: 6007535
• Product Code: MBH
• UDI-Device Identifier: 07613327050448
• UDI-Public: 07613327050448
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2023

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: 01/31/2019
• Device Model Number: 5530-G-311
• Device Catalogue Number: 5530-G-311
• Device Lot Number: MNAJJ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 80 KG