MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE4 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G413

Device Problems Degraded (1153); Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 07/31/2023

Event Type  Injury  

Event 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.

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 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.Per medical review: "there is a fracture of the inferior pole of the patella present" which reportedly "fully healed" without medical intervention.

Manufacturer Narrative

An event regarding crack/fracture involving a triathlon insert 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 indicated that the locking wire has fractured off.Material deformation near the locking mechanism of the device and scratches along the underside are also observed.It appears two fragments of metal have become embedded in the underside of the device.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.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 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." visual inspection of the returned device indicated that the locking wire has fractured off.Material deformation near the locking mechanism of the device and scratches along the underside are also observed.It appears two fragments of metal have become embedded in the underside of the device.The yellow discoloration observed on the tibial insert is consistent with the absorption of synovial fluid by the device.The damage observed on the insert was likely sustained as a result of the baseplate fracture.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.

Manufacturer Narrative

Reported event: an event regarding crack/fracture and wear involving a triathlon insert 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 depicted in figure shows the tibial baseplate with fracture location highlighted by the arrow.Also included in the image are the femoral component and the tibial insert with arrow highlighting detached piece of locking wire from the tibial insert.Image depicted in figure shows the articulating surface of the tibial insert.Slight yellow discolouration consistent with oxidation, possibly a result of synovial fluid absorption, was observed on the insert [1].Figure shows the distal surface of the insert with embedded material observed.Stereo microscope imaging was performed on the tibial insert.Burnishing, scratching, third body indentations and embedded debris were observed on the articulating surface of the insert.While embedded debris was also observed on the distal surface of the insert.Burnishing is caused by adhesive/abrasive wear of the insert against the femoral component.Scratching and indentations are caused by third body debris trapped between the insert and femoral component during articulating.Burnishing, scratching, third body indentations and embedded debris are consistent with commonly identified damage modes in uhmwpe inserts [2].The anterior surface of the insert is shown in figure with explantation damage observed.Figure shows stereo microscope images of both fracture surfaces of the detached piece of the locking wire." material analysis: a material analysis was performed on the returned device which indicated the following: "review of tritanium baseplate, catalogue # 5536-b-400, lot code: ctd6388 and x3 tibial insert, catalogue#: 5531-g-413, lot code: ldz024 confirmed fracture of the baseplate and fracture of the locking wire of the insert.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.Visual analysis identified detachment of the posterior-medial and anterior-lateral pegs from the baseplate.Characterisation using stereo microscopy confirmed the presence of embedded debris on both the articulating and distal surfaces of the insert.Scanning electron microscopy confirmed fracture of the locking wire in fatigue, with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined." -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 material analysis was performed on the returned devices which indicated the following: "review of tritanium baseplate, catalogue#: 5536-b-400, lot code: ctd6388 and x3 tibial insert, catalogue#: 5531-g-413, lot code: ldz024 confirmed fracture of the baseplate and fracture of the locking wire of the insert.Characterisation using stereo microscopy and scanning electron microscopy confirmed fracture through the baseplate in fatigue.Visual analysis identified detachment of the posterior-medial and anterior-lateral pegs from the baseplate.Characterisation using stereo microscopy confirmed the presence of embedded debris on both the articulating and distal surfaces of the insert.Scanning electron microscopy confirmed fracture of the locking wire in fatigue, with final fracture in overload.No manufacturing or material related defects were observed on the device surfaces examined." a review of the provided medical records by a clinical consultant indicated: "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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event 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 on (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.Per medical review: "there is a fracture of the inferior pole of the patella present" which reportedly "fully healed" without medical intervention.

• Brand Name: X3 TRIATHLON CS INS SIZE4 13MM
• Type of Device: 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: 17609798
• MDR Text Key: 321801289
• Report Number: 0002249697-2023-00930
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045819
• UDI-Public: 07613327045819
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 5531G413
• Device Lot Number: LDZ024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 10/09/2023; 01/08/2024
• Supplement Dates FDA Received: 11/06/2023; 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 127 KG