MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S4; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5536B400
Medical Device Problem Codes	Fracture (1260); Osseointegration Problem (3003)
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.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and loosening/subsidence involving a triathlon baseplate was reported.The crack/fracture event was confirmed via evaluation of the returned device and loosening/subsidence was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: visual inspection of the returned device was performed as part of the material analysis: "image depicted 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.On visual examination, fracture of the medial side of the baseplate was observed.The posteriormedial peg and anterior-lateral peg were also observed to be detached from the baseplate.[.] shows a stereo microscope image of the full fracture surface associated with the posterior side of the baseplate while shows the full fracture surface associated with the anterior side, with the approximate fracture origin location (o) highlighted.Shows stereo microscope images of the missing (a) posterior-medial peg and (b) anterior-lateral peg.Significant surface material damage was observed where the pegs were missing.Shows stereo microscope images of the fracture surfaces of both detached pegs." material analysis: a material analysis was performed on the returned device which concluded 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 information 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 concluded 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 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.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 BPLATE TRIATHLON S4
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17609797
• Report Number: 0002249697-2023-00929
• Device Sequence Number: 6422256
• Product Code: MBH
• UDI-Device Identifier: 07613327041491
• UDI-Public: 07613327041491
• 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
• Report Date (Section B): 01/16/2024

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: 03/31/2020
• Device Catalogue Number: 5536B400
• Device Lot Number: CTD6388
• 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: 12/22/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2015
• 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: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 127 KG