MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON #7 CS ALLPOLY 13MM; TRIATHLON #1 CS ALLPOLY 9MM

Catalog Number	5534A713
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032)
Date of Event	12/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon p/a cr beaded #7r; cat#5517f702 ; lot# ddh4d.Triathlon asymmetric x3 patella; cat#5551-g-401; lot# pa98.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.
Event or Problem Description
All poly tibia study: as noted on the 6yr visit of the follow-up questionnaire (collected over the phone), the subject noted yes and no to their satisfaction with the right knee replacement.The surgery fixed the pain and allowed to walk, but the entire process has not met expectations.The patient is having difficulty walking due to stiffness.The subject has not had surgery on the knee since the last study visit/contact.
Event or Problem Description
All poly tibia study: as noted on the 6yr visit of the follow-up questionnaire (collected over the phone), the subject noted yes and no to their satisfaction with the right knee replacement.The surgery fixed the pain and allowed to walk, but the entire process has not met expectations.The patient is having difficulty walking due to stiffness.The subject has not had surgery on the knee since the last study visit/contact.
Additional Manufacturer Narrative
Reported event: an event regarding range of motion (rom) involving a triathlon tibial component 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: "the office note dated (b)(6)2024 describes a patient that is pain free and ambulating normally.Active range of motion is 0-120.Ap and lateral x-rays show a cemented tka with an all-polyethylene tibia in anatomic position with pristine bone cement interfaces.No harms or hazards were seen in this review.Should further documentation become available i would be happy to further this investigation." -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: it as reported that the patient is experiencing stiffness.A review of the provided medical records by a clinical consultant indicated: "the office note dated (b)(6)2024 describes a patient that is pain free and ambulating normally.Active range of motion is 0-120.Ap and lateral x-rays show a cemented tka with an all-polyethylene tibia in anatomic position with pristine bone cement interfaces.No harms or hazards were seen in this review.Should further documentation become available i would be happy to further this investigation." no further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON #7 CS ALLPOLY 13MM
• Common Device Name: TRIATHLON #1 CS ALLPOLY 9MM
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21144262
• Report Number: 0002249697-2025-00066
• Device Sequence Number: 13035953
• Product Code: MBH
• UDI-Device Identifier: 07613327043396
• UDI-Public: 07613327043396
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 07/31/2018
• Device Catalogue Number: 5534A713
• Device Lot Number: 224669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/08/2018
• 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: Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White