MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 6; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-600
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: triathlon asym patella a38x11; cat# 5551l381; lot# lct627.Triathlon ps x3 tibial insert; cat# 5532-g-609; lot# mld7p7.Triathlon ps fem component, cemented; cat# 5515-f-501; lot# giona.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.
Event or Problem Description
It was reported through the communication of an attorney that allegedly the patient was revised due to "persistent left knee pain and patient status post left total knee arthroplasty with overhanging tibial component.".
Additional Manufacturer Narrative
Reported event: an event regarding pain involving a triathlon baseplate was reported.The event was not confirmed.Method & results: -product evaluation and results: not performed as no product was returned for evaluation.- clinician review: a review of medical records by a clinician indicated "confirmation of event: i can confirm that the patient underwent a primary left total knee arthroplasty on (b)(6) 2012 and a revision left total knee arthroplasty on (b)(6) 2017.I can confirm these procedures because i was able to review the operation reports.Root cause analysis: the root cause of this event can be determined with certainty.The cause of a painful knee due to tibial component medial overhang after total knee arthroplasty is iatrogenic in nature.Primary total knee arthroplasty should be performed so that the components do not overhang the bone because this can cause impingement on the soft tissues thereby causing pain.No causality should be attributed to the patient or the implant.-product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of medical records by a clinician indicated "confirmation of event: i can confirm that the patient underwent a primary left total knee arthroplasty on (b)(6) 2012 and a revision left total knee arthroplasty on (b)(6) 2017.I can confirm these procedures because i was able to review the operation reports.Root cause analysis: the root cause of this event can be determined with certainty.The cause of a painful knee due to tibial component medial overhang after total knee arthroplasty is iatrogenic in nature.Primary total knee arthroplasty should be performed so that the components do not overhang the bone because this can cause impingement on the soft tissues thereby causing pain.No causality should be attributed to the patient or the implant.The event itself could not be confirmed and exact cause of the event could not be determined because insufficient information was provided.Further information such as device return, pre and post operative x-rays, operative reports as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No new information.

• Brand Name: TRI TS BASEPLATE SIZE 6
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 8717506
• Report Number: 0002249697-2019-02327
• Device Sequence Number: 16599729
• Product Code: MBH
• UDI-Device Identifier: 07613327026337
• UDI-Public: 07613327026337
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 05/31/2017
• Device Catalogue Number: 5521-B-600
• Device Lot Number: HFVZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2012
• 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: Hospitalization; Required Intervention
• Patient Sex: Male