MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S2; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5536-B-200

Device Problems Fracture (1260); Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Inadequate Osseointegration (2646)

Event Date 03/07/2023

Event Type  Injury  

Event Description

Revised a right triathlon total knee originally done (b)(6) 2022 due to aseptic loosening, possible infection.Intra-op he noticed when removing the tibial baseplate, the posterior-medial peg was sheared off.Dr.Didn't believe it happened due to his technique of extraction as the baseplate was already loose.He is not sure how or when it could have happened.He revised to a triathlon ts knee.He did not revise the patella component.

Manufacturer Narrative

It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.The following devices were also listed in this report: triathlon p/a cr beaded #3r; cat#: 5517f302; lot#: ny23r.X3 triathlon cs insert #2 9mm; cat#: 5531-g-209-e; lot#: kl5780.Tritanium patella-asymmetric; cat#: 5552-l-320; lot#: tj4m1.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Revised a right triathlon total knee originally done on (b)(6) 2022 due to aseptic loosening, possible infection.Intra-op he noticed when removing the tibial baseplate, the posterior-medial peg was sheared off.Dr.Didn't believe it happened due to his technique of extraction as the baseplate was already loose.He is not sure how or when it could have happened.He revised to a triathlon ts knee.He did not revise the patella component.

Manufacturer Narrative

An event regarding crack/fracture, loosening/subsidence, and infection 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.Infection 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: "on visual examination, it was observed that the posterior-medial peg was missing and porous coating surrounding the peg.Bone growth was also observed on the distal surface of the baseplate.Stereo microscope reviewed missing posterior-medial peg.An area of damage to the porous coating can also be observed near where the peg is missing.Significant surface material damage was observed where the peg was missing." material analysis: a material analysis was performed on the returned device which concluded the following: "review of tritanium baseplate, catalogue#: 5536-b-200, lot code: ctd76750 confirmed detachment of material from the peg.Characterisation using stereo microscopy and scanning electron microscopy confirmed loss of material from the posterior-medial peg.Significant damage to the area has hindered identification of the origin of the material loss.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 patient required revision of a cementless triathlon total knee arthroplasty eight months following implantation due to loosening and possible infection.No supporting documentation was given and only a single ap x-ray was provided.I can confirm that the primary procedure occurred since i was able to look at an x-ray prior to revision.I can only confirm that the revision took place since the usage sheet confirmed reimplantation.I cannot determine the root cause of this event with certainty.The causes of early failure of a cementless total knee arthroplasty are multifactorial including surgical technique of implantation and fixation, patient factors such as bmi and activity level.In this case the possibility of infection must be considered.Regarding the shearing off of the base plate peg this can be caused by abnormal forces placed on the implant.The femoral component was in considerable varus in the tibial component had subsided laterally.Upon weight bearing this could contribute to breakage of the peg." 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.There has been 1 other similar event for the sterile lot referenced which relates to infection.Conclusions: it was reported that the patient was revised due to loosening and possible infection.Intraoperatively, fracture of one of the pegs of the baseplate was observed.A review of the provided x-ray image by a clinician indicated the following: "i cannot determine the root cause of this event with certainty.The causes of early failure of a cementless total knee arthroplasty are multifactorial including surgical technique of implantation and fixation, patient factors such as bmi and activity level.In this case the possibility of infection must be considered.Regarding the shearing off of the base plate peg this can be caused by abnormal forces placed on the implant.The femoral component was in considerable varus in the tibial component had subsided laterally.Upon weight bearing this could contribute to breakage of the peg." a material analysis was performed on the returned device which concluded the following: "review of tritanium baseplate, catalogue#: 5536-b-200, lot code: ctd76750 confirmed detachment of material from the peg.Characterisation using stereo microscopy and scanning electron microscopy confirmed loss of material from the posterior-medial peg.Significant damage to the area has hindered identification of the origin of the material loss.No manufacturing or material related defects were observed on the device surfaces examined." all stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.Further information such as pathology reports, additional pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.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: TRITANIUM BPLATE TRIATHLON S2
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16642403
• MDR Text Key: 312285765
• Report Number: 0002249697-2023-00329
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327041590
• UDI-Public: 07613327041590
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5536-B-200
• Device Catalogue Number: 5536B200
• Device Lot Number: CTD76750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• 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: 82 YR
• Patient Sex: Female