MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI CEMENTED STEM 12MMX50MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	5560-S-112
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Joint Laxity (4526); Periprosthetic fracture (4902)
Date of Event	12/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: right knee revision surgery today.The previous revision surgery was from another company¿s knee to stryker.The revision today was due to pain and instability.During implant removal most of the distal femur came off with the femoral implant so it was necessary to go to a gmrs implant.No further information is available from the doctor or hospital.Update on 29 apr 2026 based on medical review: tibia with loosening seen around the tibial stem.Implant has fallen into varus, and the medial plateau is collapsed.The tibial stem is impinging on the lateral cortex.Femoral component not clearly loose but in significant extension on the lateral view.
Additional Manufacturer Narrative
Reported event: an event regarding loosening involving a triathlon stem was reported.The event was confirmed via clinical review.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: a review of the provided medical records by a clinical consultant indicated: "conclusion/assessment: no medical records, patient history, sequential x-rays, or exams were provided for review.Based on the images, the pi report and implant usage sheets, a tka was revised to a stryker component.The reasons for revision and prior implant were not defined.The revision went on to become painful and loose.Again, the history leading to the revision was not provided.At revision, there was removal of the distal femoral bone, presumably inadvertent, that required revision to a hinged mrh construct.The outcome of the surgery and postoperative course were not provided for review.Event confirmation: a revision right knee surgery to a stryker component can be confirmed.The reasons for revision and prior component cannot be confirmed.The revision was for loosening which can be confirmed and for pain that cannot be confirmed.The revision components were a mrh hinge based on the implant usage sheets.Root cause: the root cause of the primary tka and the initial revision cannot be ascertained based on the information provided for review.The reason for revision of the stryker component was loosening and reported pain.The need for the mrh implant was femoral bone loss at the time of revision." product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: it was reported that "tibia with loosening seen around the tibial stem.Implant has fallen into varus, and the medial plateau is collapsed".The event was confirmed via medical review.The root cause of this event cannot be determined with certainty.As clinician indicated, "the root cause of the primary tka and the initial revision cannot be ascertained based on the information provided for review.The reason for revision of the stryker component was loosening and reported pain.The need for the mrh implant was femoral bone loss at the time of revision." 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.

• Brand Name: TRI CEMENTED STEM 12MMX50MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 25213874
• Report Number: 0002249697-2026-00413
• Device Sequence Number: 21465881
• Product Code: JWH
• UDI-Device Identifier: 07613327026528
• UDI-Public: 07613327026528
• 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: 2017
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2026

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: 04/05/2022
• Device Catalogue Number: 5560-S-112
• Device Lot Number: 0057043A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2017
• 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: 67 YR
• Patient Sex: Male