MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #2L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F201
Medical Device Problem Codes	Mechanical Problem (1384); Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, 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 reported discrepancies.There have been no other events for the lot referenced.H3 other text : device is still implanted.
Event or Problem Description
Patient reported left knee pain and noted product is "too large".Patient is scheduled for a revision on march 21st.As per medical review: x-rays revealed "within four months the patient was complaining of pain and stiffness and went for second opinions who felt her femoral component could be too large causing stuffing of the joint.The patient apparently is scheduled for revision surgery.Only a single ap view of the knee was provided to me so i cannot adequately assess sizing with certainty.".
Additional Manufacturer Narrative
Reported event: an event regarding malposition involving a triathlon femoral component was reported.The event was confirmed via medical review.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 additional radiographs confirm that the femoral implant is at the very least hyper flexed, out of the range of acceptability.It may well be oversized as well which can only be determined using digital or acetate templates.The tibial implant is also hyper flexed with some posterior overhang.In my opinion, coupling the hyper flexion of the femoral component with an unresurfaced patella, that certainly can cause impingement with pain and stiffness that can result in the need for revision surgery, possibly of all components with most likely resurfacing of the patella.I would consider this an iatrogenic situation." 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: patient reported left knee pain and noted product is "too large".A review of the provided medical records by a clinical consultant indicated: "the additional radiographs confirm that the femoral implant is at the very least hyper flexed, out of the range of acceptability.It may well be oversized as well which can only be determined using digital or acetate templates.The tibial implant is also hyper flexed with some posterior overhang.In my opinion, coupling the hyper flexion of the femoral component with an unresurfaced patella, that certainly can cause impingement with pain and stiffness that can result in the need for revision surgery, possibly of all components with most likely resurfacing of the patella.I would consider this an iatrogenic situation." no further investigation for this event is possible at this time.If devices and/or additional information become available after revision surgery to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient reported left knee pain and noted product is "too large".Patient is scheduled for a revision on march 21st.As per medical review: "the additional radiographs confirm that the femoral implant is at the very least hyper flexed, out of the range of acceptability.It may well be oversized as well which can only be determined using digital or acetate templates.The tibial implant is also hyper flexed with some posterior overhang.".

• Brand Name: TRIATHLON P/A CR BEADED #2L
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18921744
• Report Number: 0002249697-2024-00432
• Device Sequence Number: 12364956
• Product Code: MBH
• UDI-Device Identifier: 07613327040906
• UDI-Public: 07613327040906
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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 Catalogue Number: 5517F201
• Device Lot Number: NYX2C1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2021
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 63 KG