MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #2 PS INSERT 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532P216
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	03/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding 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 remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a primary right cemented total knee arthroplasty with a competitor implant because i was able to see an x-ray showing the implant.I can also confirm that the patient had a revision of that implant since i was able to review the operation report and examine post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of stiffness, or arthrofibrosis, following total knee arthroplasty are multifactorial including surgical technique especially in the size, positioning, fixation, alignment, and restoration of kinematics, as well as patient factors including activity level, lifestyle, bmi, and the ability to cooperate with a postoperative rehabilitation program.In addition, there are patients who are prone to form scar tissue." product 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.Conclusions: patient reported a left knee pain and manipulation under anesthesia due to limited range of motion.A review of the provided medical records by a clinical consultant indicated: "a review of the provided medical records by a clinical consultant indicated: "i can confirm that the patient underwent a primary right cemented total knee arthroplasty with a competitor implant because i was able to see an x-ray showing the implant.I can also confirm that the patient had a revision of that implant since i was able to review the operation report and examine post revision x-rays.Root cause analysis: the root cause of this event cannot be determined with certainty.The causes of stiffness, or arthrofibrosis, following total knee arthroplasty are multifactorial including surgical technique especially in the size, positioning, fixation, alignment, and restoration of kinematics, as well as patient factors including activity level, lifestyle, bmi, and the ability to cooperate with a postoperative rehabilitation program.In addition, there are patients who are prone to form scar tissue." 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: cat# 5512-f-302; tri ts femur sz3 right; lot# whut.Cat# 5521-b-200; tri ts baseplate size 2: lot# w4lba.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
The subject presented into clinic on (b)(6) 2017 and was evaluated to reach almost 90 degrees in flexion.Doctor diagnosed stiffness status post right tka and scheduled a mua for (b)(6) 2017.No further complaints noted.

• Brand Name: TRIATHLON #2 PS INSERT 16MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20299274
• Report Number: 0002249697-2024-01320
• Device Sequence Number: 20769691
• Product Code: MBH
• UDI-Device Identifier: 07613327042610
• UDI-Public: 07613327042610
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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: 04/30/2020
• Device Catalogue Number: 5532P216
• Device Lot Number: LEH699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/14/2015
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White