MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5530-G-209
Medical Device Problem Codes	Degraded (1153); Fracture (1260); Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Joint Laxity (4526)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised.As reported: "pain and deformity." a baseplate, insert, and patellar component were revised.
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.Device not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's left knee was revised.As reported: "pain and deformity." a baseplate, insert, and patellar component were revised.
Additional Manufacturer Narrative
Reported event: an event regarding instability and wear involving a triathlon insert was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection: the devices were not returned however photographs were provided for review.A review of the photographs indicated recently explanted devices covered in blood and tissue.The insert was observed to have dents/damage and portions fractured off consistent with articulation against hard object and attempted explantation.Material analysis, functional, and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of medical records by clinical consultant indicated " as i described above this inquiry reports the failure of a cementless triathlon total arthroplasty about nine years after initial implantation due to polyethylene wear and instability.Severe poly wear in an x3 insert is rare in my experience of over 18 years with triathlon, cemented and cementless.Causes are multifactorial including surgical technique, patient factors and implant factors.This patient has a bmi of over 45 which can cause overload and poly wear." -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 the patient was revised due to polyethylene wear and instability.The devices were not returned however photographs were provided for review.A review of the photographs indicated recently explanted devices covered in blood and tissue.The insert was observed to have dents/damage and portions fractured off consistent with articulation against hard object and attempted explantation.A review of medical records by clinical consultant indicated " as i described above this inquiry reports the failure of a cementless triathlon total arthroplasty about nine years after initial implantation due to polyethylene wear and instability.Severe poly wear in an x3 insert is rare in my experience of over 18 years with triathlon, cemented and cementless.Causes are multifactorial including surgical technique, patient factors and implant factors.This patient has a bmi of over 45 which can cause overload and poly wear." 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: TRIATHLON CR X3 TIBIAL INSERT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14846450
• Report Number: 0002249697-2022-00940
• Device Sequence Number: 2382015
• Product Code: MBH
• UDI-Device Identifier: 07613327046410
• UDI-Public: 07613327046410
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K051146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2022

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 Expiration Date: 04/30/2018
• Device Model Number: 5530-G-209
• Device Catalogue Number: 5530-G-209
• Device Lot Number: LDG994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2013
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 101 KG