MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #4 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5510-F-402
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device noted as returned.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's right knee was revised.Intra-operatively, the posterior aspect of the medial condyle of the femoral component was broken from the rest of the implant, resulting in damage to the insert.A size 3 cr femur and size 3 cr insert were revised to a size 4 ts femur and another insert.Incident occurred during a revision total knee arthroplasty in which the femoral component (5510-f-402) was fractured at the medial distal surface.As well as significant wear on the medial bearing surface of the polyethylene.The tibial baseplate (5520-b-300) remained well-fixed, therefore was not revised.The femoral component was revised with a rt ts size 4 femur comprised of a 5mm augment distal medial, 5mm augment posterior medial, and a 15mm x 50mm cemented stem.The polyethylene was revised with a size 3 x 16mm posterior stabilized insert.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving a triathlon femoral component was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "image represents cemented cr femoral component with fracture and cr tibial insert fracture surfaces associated with the femoral component and the detached piece.On visual examination, the fracture was observed through the medial condyle of the femoral component." material analysis: a material analysis was performed and concluded the following: "review of no 4 cemented cr femoral component, catalogue # 5510-f-402, lot code s6dat confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the medial condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the component." clinician review: a review of the provided medical information by a clinical consultant indicated: "conclusion of assessment: this inquiry reports the revision of a total knee arthroplasty on february 1, 2022 for fracture of the femoral component.No implant date was reported.I cannot confirm that this event took place since i was not able to see any documentation such as office notes, revision operation notes, photos of explants and complete preop and post op radiographs.Regarding the possible root cause of this event, i cannot determine it with certainty.Causes of fracture of a femoral component are multifactorial including surgical technique factors, patient activity factors (such as height, weight, activity level and bmi), and implant factors." 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 the patient was revised due to fracture of the femoral component.A material analysis was performed on the returned device and concluded the following: "review of no 4 cemented cr femoral component, catalogue # 5510-f-402, lot code s6dat confirmed fracture of the device.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture of the medial condyle in fatigue.No manufacturing or material related defects were observed on the examined areas of the component." 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.
Event or Problem Description
It was reported that the patient's right knee was revised.Intra-operatively, the posterior aspect of the medial condyle of the femoral component was broken from the rest of the implant, resulting in damage to the insert.A size 3 cr femur and size 3 cr insert were revised to a size 4 ts femur and another insert.Incident occurred during a revision total knee arthroplasty in which the femoral component (5510-f-402) was fractured at the medial distal surface.As well as significant wear on the medial bearing surface of the polyethylene.The tibial baseplate (5520-b-300) remained well-fixed, therefore was not revised.The femoral component was revised with a rt ts size 4 femur comprised of a 5mm augment distal medial, 5mm augment posterior medial, and a 15mm x 50mm cemented stem.The polyethylene was revised with a size 3 x 16mm posterior stabilized insert.

• Brand Name: TRIATHLON CR FEM COMP #4 R-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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13609947
• Report Number: 0002249697-2022-00282
• Device Sequence Number: 1957138
• Product Code: MBH
• UDI-Device Identifier: 07613327040289
• UDI-Public: 07613327040289
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K040267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 08/31/2016
• Device Model Number: 5510-F-402
• Device Catalogue Number: 5510F402
• Device Lot Number: S6DAT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2011
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 64 KG