MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F302
Medical Device Problem Codes	Degraded (1153); Fracture (1260); 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
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no similar events for the lot referenced.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.H3 other text : not returned to the manufacturer.
Event or Problem Description
Patient had initial knee replacement approximately 8 years ago.Triathlon tritanium.Patient came to see dr.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.
Event or Problem Description
Patient had initial knee replacement approximately 8 years ago.Triathlon tritanium.Patient came to see dr.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 7/31.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.Per medical review: "there is a fracture of the inferior pole of the patella present" which reportedly "fully healed" without medical intervention.
Additional Manufacturer Narrative
Reported event: an event regarding periprosthetic fracture and wear involving a triathlon femoral component was reported.Wear was confirmed via evaluation of the returned device.Periprosthetic fracture of the femur was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "bone growth was observed on the proximal surface of the femoral component and on the distal surface of the baseplate.Burnishing was observed on the articulating surface of the femoral component, likely a result of contact with another material." material analysis: a material analysis was performed on the returned device which indicated the following: "figure shows the eds spectrum for the area of burnishing shown in figure.Elemental constituents included carbon, cobalt, chromium, molybdenum and silicon.The high peak for carbon indicates contact with another material, likely a result of abrasion against the tibial insert.Figure shows the eds spectrum for the area of burnishing shown in figure.Elemental constituents included cobalt, chromium, titanium, molybdenum, silicon and aluminium.The presence of titanium and aluminium are consistent with contact with material from the baseplate [4]." 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 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 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 did not confirm the reported femoral periprosthetic fracture.A review of the returned device indicated that the articulating surface of the femoral component exhibited burnishing consistent with contact with material from the insert and the baseplate.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient had initial knee replacement approximately 8 years ago.Triathlon tritanium.Patient came to see dr.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 7/31.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.Per medical review: "there is a fracture of the inferior pole of the patella present" which reportedly "fully healed" without medical intervention.
Additional Manufacturer Narrative
An event regarding periprosthetic fracture involving a triathlon femoral component was reported.The event was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated nothing remarkable.Minor damage consistent with contact with explantation tooling and/or time spent implanted is observed.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 devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: could not be performed as the device lot details were not provided.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.

• Brand Name: TRIATHLON P/A CR BEADED #3R
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 17609799
• Report Number: 0002249697-2023-00928
• Device Sequence Number: 6422257
• Product Code: MBH
• UDI-Device Identifier: 07613327040951
• UDI-Public: 07613327040951
• 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,Followup,Followup
• Report Date (Section B): 01/31/2024

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 Expiration Date: 02/28/2020
• Device Catalogue Number: 5517F302
• Device Lot Number: EMM4K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 10/09/2023; 01/08/2024
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 11/06/2023; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2015
• 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