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-309

Device Problems Degraded (1153); Insufficient Information (3190)

Patient Problems Joint Laxity (4526); Insufficient Information (4580)

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

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.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.Device not returned to the manufacturer.

Event Description

The following was reported: polyethylene insert was revised after 5 years post surgery.

Event Description

The following was reported: polyethylene insert was revised after 5 years post surgery.

Manufacturer Narrative

Reported event: an event regarding wear involving a triathlon insert was reported.The event was confirmed via evaluation of the returned device and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.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.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this case concerns a female patient who underwent a cemented primary cruciate retaining triathlon total knee arthroplasty.Approximately five years later the patient required revision for polyethylene wear and anterior tibial subluxation.I can confirm that the primary procedure took place and that a revision procedure took place since i can see a post revision x-ray and the date of explant was noted in the summary.However i do not have any further documentation of the revision procedure.I cannot determine the root cause of this event with certainty.The root causes of polyethylene wear with anterior subluxation are multifactorial.These include surgical technique factors, patient factors including activity level and bmi and implant factors.With a posterior cruciate ligament retaining implant if the posterior cruciate ligament is left relatively tight, that creates a relatively tight flexion space which can result in wear of the polyethylene posteriorly.Ligament balancing and restoration of kinematics also impact the wear of polyethylene." -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.Conclusion: it was reported that the patient was revised.Visual inspection of the returned device indicated that the insert is worn.The damage present on the posterior portion was consistent with delamination and material loss.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.A review of the provided medical records by a clinical consultant indicated the following: "this case concerns a female patient who underwent a cemented primary cruciate retaining triathlon total knee arthroplasty.Approximately five years later the patient required revision for polyethylene wear and anterior tibial subluxation.I cannot determine the root cause of this event with certainty.The root causes of polyethylene wear with anterior subluxation are multifactorial.These include surgical technique factors, patient factors including activity level and bmi and implant factors.With a posterior cruciate ligament retaining implant if the posterior cruciate ligament is left relatively tight, that creates a relatively tight flexion space which can result in wear of the polyethylene posteriorly.Ligament balancing and restoration of kinematics also impact the wear of polyethylene." 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.Correction - d6a.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• Type of Device: 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16450866
• MDR Text Key: 310326971
• Report Number: 0002249697-2023-00197
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327050431
• UDI-Public: 07613327050431
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K051146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 5530-G-309
• Device Catalogue Number: 5530-G-309
• Device Lot Number: 2325EM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female