MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM BPLATE TRIATHLON S3; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5536-B-300
Medical Device Problem Codes	Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.Should additional information become available, 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 relevant reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
It was reported that the patient's right knee was revised.As reported: "patient had her tibia and poly revised due to subsidence." rep provided an x-ray, primary and revision usage sheets.No further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence involving a triathlon baseplate was reported.The event was not confirmed.Method & results: device evaluation and results: material analysis, visual inspection, functional and dimensional inspections could not be performed because the device was not returned.Clinician review: a review of medical records with a clinical consultant indicated "this inquiry concerns the case of a 75-year-old woman who underwent a primary cementless total knee arthroplasty that had to be revised within two months for subsidence of the tibial component.I can confirm that this event occurred since i was able to see the x-ray that showed the tibial abnormality.Only one x-ray was provided.The causes of early failure of a cementless totally arthroplasty in the absence of trauma is likely related to surgical technique including the assessment of bone quality.Implants that are undersized or not properly aligned or positioned can fail early.If the kinematics of the knee are not satisfactory, with ligament laxity, this is also a cause of early failure.I would not attribute any causation of failure to the implant itself." device 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 reported lot.Conclusion: it was reported that the patient was revised due to subsidence.A review of medical records with a clinical consultant indicated "this inquiry concerns the case of a 75-year-old woman who underwent a primary cementless total knee arthroplasty that had to be revised within two months for subsidence of the tibial component.I can confirm that this event occurred since i was able to see the x-ray that showed the tibial abnormality.Only one x-ray was provided.The causes of early failure of a cementless totally arthroplasty in the absence of trauma is likely related to surgical technique including the assessment of bone quality.Implants that are undersized or not properly aligned or positioned can fail early.If the kinematics of the knee are not satisfactory, with ligament laxity, this is also a cause of early failure.I would not attribute any causation of failure to the implant itself." 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
It was reported that the patient's right knee was revised.As reported: "patient had her tibia and poly revised due to subsidence." rep provided an x-ray, primary and revision usage sheets.No further information will be released by the hospital or surgeon.

• Brand Name: TRITANIUM BPLATE TRIATHLON S3
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15263738
• Report Number: 0002249697-2022-01196
• Device Sequence Number: 6504517
• Product Code: MBH
• UDI-Device Identifier: 07613327041484
• UDI-Public: 07613327041484
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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 Model Number: 5536-B-300
• Device Catalogue Number: 5536B300
• Device Lot Number: CTD75402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/22/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: 75 YR
• Patient Sex: Female