MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM PATELLA-ASYMMETRIC; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5552-L-350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	07/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a triathlon patella 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 was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: "this case consists of a patient who underwent a bilateral total knee arthroplasty procedure, developed pain, sustained inferior pole patella fractures and subsequently developed a fractured tibial baseplate on the right with backside polyethylene wear and fracture of the locking mechanism, all requiring revision surgery with a triathlon ts implant.I can confirm that the patient had the primary procedures because i was able to review the operation reports and some postoperative x-rays.I cannot confirm the revision procedure since i have no documentation such as office notes, operation note or post revision x-rays.I can confirm that the fracture of the base plate occurred and that the fracture of the locking mechanism occurred with backside where and embedding of at least two metal pieces on the under surface of the tibial polyethylene because i was able to see photographs of the devices.The root cause of this event cannot be determined with certainty.The causes of fracture of the tibial baseplate with the associated findings described above are multifactorial.These factors include surgical technique factors, possible trauma, although no trauma was mentioned in the history, patient factors including activity level in bmi, and implant factors.In this case the tibial component was placed in varus and the patient has an elevated bmi which certainly can contribute to the fracture.If fixation was achieved preferentially laterally with some lack of fixation immediately, then a stress fracture could occur due to a cantilever type affect." -product history review: review of the device history records indicate (b)(4) devices were manufactured and accepted into final stock on (b)(6), 2015 with no relevant reported discrepancies.-complaint history review: there has been 1 other similar event for the lot referenced which relates to periprosthetic fracture for the same device/patient; therefore, no further trending is required for this commonality.Conclusions: it was reported that the patient was revised due to fracture of the tibial baseplate as well as the lateral posterior proximal femur.Fracture of the locking mechanism of the tibial insert was observed intraoperatively.It was also reported that the patient had sustained a prior periprosthetic fracture of the patella.A review of the provided medical records by a clinical consultant indicated: "this case consists of a patient who underwent a bilateral total knee arthroplasty procedure, developed pain, sustained inferior pole patella fractures and subsequently developed a fractured tibial baseplate on the right with backside polyethylene wear and fracture of the locking mechanism, all requiring revision surgery with a triathlon ts implant.I can confirm that the patient had the primary procedures because i was able to review the operation reports and some postoperative x-rays.I cannot confirm the revision procedure since i have no documentation such as office notes, operation note or post revision x-rays.I can confirm that the fracture of the base plate occurred and that the fracture of the locking mechanism occurred with backside where and embedding of at least two metal pieces on the under surface of the tibial polyethylene because i was able to see photographs of the devices.The root cause of this event cannot be determined with certainty.The causes of fracture of the tibial baseplate with the associated findings described above are multifactorial.These factors include surgical technique factors, possible trauma, although no trauma was mentioned in the history, patient factors including activity level in bmi, and implant factors.In this case the tibial component was placed in varus and the patient has an elevated bmi which certainly can contribute to the fracture.If fixation was achieved preferentially laterally with some lack of fixation immediately, then a stress fracture could occur due to a cantilever type affect." 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
Patient had initial knee replacement approx 8 years ago.Triathlon tritanium.She came to see dr.Sharpe in clinic with knee pain.X rays were taken and revealed that the tibial baseplate was broken as well as the lateral posterior proximal femur.Revision surgery was (b)(6).Once the knee was opened, we noticed the locking wire on poly was broken as well.Metal was floating around the joint and ended up underneath the poly where it was work into the backside of the plastic.All implants were removed and revised with triathlon ts.Right knee.Per medical review of x-ray image dated (b)(6), 2016: "there is a fracture of the inferior pole of the patella present" which reportedly "fully healed" without medical intervention.

• Brand Name: TRITANIUM PATELLA-ASYMMETRIC
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18037142
• Report Number: 0002249697-2023-01290
• Device Sequence Number: 7429033
• Product Code: MBH
• UDI-Device Identifier: 07613327013559
• UDI-Public: 07613327013559
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2023

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: 06/30/2020
• Device Catalogue Number: 5552-L-350
• Device Lot Number: A5LK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2015
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 127 KG