MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS FEMUR SZ3 LEFT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5512-F-301
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/17/2020
Type of Reportable Event	Serious Injury
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.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.
Event or Problem Description
This pi is for the intra-op (perioperative) femoral fracture.Subject received the ts system with cone augments to enroll into the stryker sponsored study 76 cones on (b)(6) 2020.There was a perioperative femoral fracture.While flexing the knee during surgery there was avulsion fracture of the medial femoral condyle fixed with cannulated screws and brace for 1mn post op.At the (b)(6) 2021 post op follow-up visit, main complaint was medial sided tenderness to palpation over areas where her cannulated screws are for medial condyle fracture during surgery and hardware irritating her and would like it removed.On (b)(6) 2021 the cannulated screws from the original surgery were removed due to hardware irritation.All information available from the study site has been provided.
Additional Manufacturer Narrative
Reported event: an event regarding intraoperative fracture involving a triathlon femoral component was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.A review of the provided medical information by a clinical consultant indicated: "i have reviewed the documentation provided for pi including the product inquiry cover sheet and previous medical assessment.In addition, i reviewed ap lateral and merchant view x-rays of a cemented revision left tka with cones at 1 year and 2 years follow up.Finally, i reviewed ap, lateral and merchant view x-rays of a revision cemented tka which also show the presence of a cannulated screws affixing the medial femoral condyle.These were taken at the 6 week and 6 month follow up time frame event description: this pi is for the intra-op (perioperative) femoral fracture.Subject received the ts system with cone augments to enroll into the stryker sponsored study 76 cones on (b)(6) 2020.There was a perioperative femoral fracture.While flexing the knee during surgery there was avulsion fracture of the medial femoral condyle fixed with cannulated screws (competitor) and brace for 1mn post op.At the (b)(6) 2021 post op follow-up visit, main complaint was medial sided tenderness to palpation over areas where her cannulated screws are for medial condyle fracture during surgery and hardware irritating her and would like it removed.On (b)(6) 2021 the cannulated screws from the original surgery were removed due to hardware irritation.All information available from the study site has been provided there is x-ray evidence of cannulated screws supporting the medial femoral condyle of a cemented revision tka.The fracture appears to have healed in anatomic position.Is confirmed.No documentation of hardware removal was provided.Orif of a medial femoral condyle fracture is confirmed." -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 was reported that 'while flexing the knee during surgery there was avulsion fracture of the medial femoral condyle fixed with cannulated screws (competitor) and brace for 1mn post op.' a review of the provided medical records by a consulting clinician indicated 'this pi is for the intra-op (perioperative) femoral fracture.Subject received the ts system with cone augments to enroll into the stryker sponsored study 76 cones on (b)(6) 2020.There was a perioperative femoral fracture.While flexing the knee during surgery there was avulsion fracture of the medial femoral condyle fixed with cannulated screws (depuy synthes) and brace for 1mn post op.At the 16mar2021 post op follow-up visit, main complaint was medial sided tenderness to palpation over areas where her cannulated screws are for medial condyle fracture during surgery and hardware irritating her and would like it removed.On (b)(6) 2021 the cannulated screws from the original surgery were removed due to hardware irritation.All information available from the study site has been provided there is x-ray evidence of cannulated screws supporting the medial femoral condyle of a cemented revision tka.The fracture appears to have healed in anatomic position.Is confirmed.No documentation of hardware removal was provided.Orif of a medial femoral condyle fracture is confirmed." 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.
Event or Problem Description
No new information.

• Brand Name: TRI TS FEMUR SZ3 LEFT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21941008
• Report Number: 0002249697-2025-00467
• Device Sequence Number: 12851628
• Product Code: MBH
• UDI-Device Identifier: 07613327026627
• UDI-Public: 07613327026627
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2025

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: 01/31/2025
• Device Catalogue Number: 5512-F-301
• Device Lot Number: EY37X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2020
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White