MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRI TS BASEPLATE SIZE 5; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5521-B-500
Medical Device Problem Codes	Loss of Osseointegration (2408); Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Left knee revision due to tibial loosening and pain.
Additional Manufacturer Narrative
Reported event: an event regarding subsidence/loosening involving a triathlon baseplate was reported.The event was confirmed via clinician review of the provided medical records.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this 97-year-old patient underwent a total knee arthroplasty with a constrained implant without stem extensions on (b)(6) 2014.The patient underwent a revision of the implant on (b)(6) 2023, ostensibly for tibial subsidence, malposition and loosening.I can confirm that the patient underwent a primary procedure with the constrained implant since i was able to review the operation report.I was also able to review the xrays which showed findings consistent with subsidence and loosening of the tibial component.The root cause of this event cannot be determined with certainty.The causes of tibial loosening of a constrained implant without stem extensions are multifactorial including surgical technique and patient activity level and bmi.The fact that a constrained implant was utilized without stem extensions can contribute to loosening.I would not assign any causality to the implant itself." 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's knee was revised due to loosening of the tibial baseplate.A review of the provided medical records by a clinical consultant indicated the following: "this 97-year-old patient underwent a total knee arthroplasty with a constrained implant without stem extensions on (b)(6) 2014.The patient underwent a revision of the implant on (b)(6) 2023, ostensibly for tibial subsidence, malposition and loosening.I can confirm that the patient underwent a primary procedure with the constrained implant since i was able to review the operation report.I was also able to review the xrays which showed findings consistent with subsidence and loosening of the tibial component.The root cause of this event cannot be determined with certainty.The causes of tibial loosening of a constrained implant without stem extensions are multifactorial including surgical technique and patient activity level and bmi.The fact that a constrained implant was utilized without stem extensions can contribute to loosening.I would not assign any causality 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.H3 other text : device not returned.

• Brand Name: TRI TS BASEPLATE SIZE 5
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17717011
• Report Number: 0002249697-2023-01009
• Device Sequence Number: 7148832
• Product Code: MBH
• UDI-Device Identifier: 07613327026320
• UDI-Public: 07613327026320
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K053514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2023

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: 11/30/2019
• Device Catalogue Number: 5521-B-500
• Device Lot Number: MIYH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 09/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2014
• 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 Sex: Male