MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-309-E
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the revision of the patient's right knee on (b)(6) 2021.In providing information for revision of patient's right knee on (b)(6) 2024, rep provided usage showing the patient had a prior revision (b)(6) 2021.Reason for revision was lack of rom.A femoral component, insert, and patellar component were revised.Rep confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding range of motion (rom) involving a triathlon insert was reported.The 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 with a clinical consultant indicated confirmation of event: i can confirm that the patient underwent right total knee arthroplasty based on the product inquiry summary and the two radiographs that were provided.Unfortunately these radiographs had no dates attached to them and did not have a side designation.I can confirm that the patient had a tritanium baseplate and a triathlon ts femoral component with a cemented patella component since i was able to see to radiographs with the implant in place.Unfortunately i have no other supporting documentation including preoperative x-rays, pre-first revision x-rays, doctors office notes or operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of a total knee arthroplasty being revised for lack of range of motion are multifactorial including surgical technique, position, rotation, alignment, and sizing, as well as restoration of proper kinematics contribute.Patient factors such as failure to participate in a physical therapy program to restore early range of motion and also patient systemic factors as there are some patients who are "scar formers." i would not attribute any causality to the implants themselves.It would be helpful to see the initial primary postoperative x-rays to see the positioning and alignment of the implants.-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: a review with a clinical consultant indicated confirmation of event: i can confirm that the patient underwent right total knee arthroplasty based on the product inquiry summary and the two radiographs that were provided.Unfortunately these radiographs had no dates attached to them and did not have a side designation.I can confirm that the patient had a tritanium baseplate and a triathlon ts femoral component with a cemented patella component since i was able to see to radiographs with the implant in place.Unfortunately i have no other supporting documentation including preoperative x-rays, pre-first revision x-rays, doctors office notes or operation reports.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of a total knee arthroplasty being revised for lack of range of motion are multifactorial including surgical technique, position, rotation, alignment, and sizing, as well as restoration of proper kinematics contribute.Patient factors such as failure to participate in a physical therapy program to restore early range of motion and also patient systemic factors as there are some patients who are "scar formers." i would not attribute any causality to the implants themselves.It would be helpful to see the initial primary postoperative x-rays to see the positioning and alignment of the implants.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.The following devices were also listed in this report: device name#triathlon p/a cr beaded #3r ; cat#5517f302 ; lot#j7x3r1.Device name#tritanium patella-asymmetric ; cat#5552-l-299 ; lot#mk3t1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

• Brand Name: X3 TRIATHLON CS INSERT NO 3 9MM
• 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-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19162772
• Report Number: 0002249697-2024-00623
• Device Sequence Number: 15312374
• Product Code: MBH
• UDI-Device Identifier: 07613327336955
• UDI-Public: 07613327336955
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2024

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: 10/31/2025
• Device Catalogue Number: 5531-G-309-E
• Device Lot Number: LKJ287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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: 77 YR
• Patient Sex: Female