MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #6 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5510F601
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "revision today was due to instability.Today the cr femur was revised to a ts femur with ts insert to address stability.No further information is available from the doctor or hospital." an x-ray and op report excerpt were provided.Left knee.Additional information from rep: there was no appearance of damage to the poly during the case.The instability seemed to be all soft tissue related, not implant failure related.Components were well fixed to bone and insert did not appear to be worn or damaged.
Additional Manufacturer Narrative
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "revision today was due to instability.Today the cr femur was revised to a ts femur with ts insert to address stability.No further information is available from the doctor or hospital." an x-ray and op report excerpt were provided.Left knee.Additional information from rep: there was no appearance of damage to the poly during the case.The instability seemed to be all soft tissue related, not implant failure related.Components were well fixed to bone and insert did not appear to be worn or damaged.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon femoral component was reported.The event was 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: aa review of medical records with a clinical consultant indicated "i have reviewed the documentation provided for pi including the product inquiry cover sheet, an operative report from the index surgery, an implant sheet from the revision surgery dated (b)(6)2024 and an ap x-ray (undated) of a cemented tka.Event description: as reported: "revision today was due to instability.Today the cr femur was revised to a ts femur with ts insert to address stability.No further information is available from the doctor or hospital." an x-ray and op report excerpt were provided.Left knee.Additional information from rep: there was no appearance of damage to the poly during the case.The instability seemed to be all soft tissue related, not implant failure related.Components were well fixed to bone and insert did not appear to be worn or damaged.Patient underwent bilateral tka surgery.The x-rays provided show the components to be well fixed however there is a significant difference in joint space with medial widening indicative of instability.Other then the implant sheet no documentation regarding the revision surgery was provided.An unstable tka requiring revision surgery is confirmed.The root cause of this instability requiring revision surgery cannot be determined from the documentation provided.' -complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of medical records with a clinical consultant indicated.'an unstable tka requiring revision surgery is confirmed.The root cause of this instability requiring revision surgery cannot be determined from the documentation provided.' 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 CR FEM COMP #6 L-CEM
• 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 21108359
• Report Number: 0002249697-2025-00048
• Device Sequence Number: 8067943
• Product Code: MBH
• UDI-Device Identifier: 07613327040319
• UDI-Public: 07613327040319
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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: 09/30/2017
• Device Catalogue Number: 5510F601
• Device Lot Number: EAESS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2012
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male