MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS #8 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G813
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	05/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported: "from the very first post-operative period, the patient has always complained of pain and joint instability in the operated right knee.After evaluation at our clinics which confirmed the joint instability, on (b)(6) 2023 the patient underwent total prosthetic reimplantation.The removed prosthetic components appeared neat, with no marks or other mechanical complication.This report is sent with delay compared to the usual times due to computer error/(pre-filled report, but subsequently missing sending to the competent offices).Planting date (b)(6) 2022 (day not known).The report concerns the entire implantation of knee prostheses.".
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.The following devices were also listed in this report: triathlon cr beaded fem #7r; cat # 5513f702; lot # nlt7e, tritanium bplate triathlon s8; cat # 5536b800; lot # ctd64103.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.H3 other text : not available.
Additional Manufacturer Narrative
Reported event: an event regarding instability involving a triathlon insert was reported.The event was not confirmed.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: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the reported device lot code was invalid.Complaint history review: could not be performed as the reported device lot code was invalid.Conclusions: it was reported that the patient was revised pain and joint instability.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, 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.
Event or Problem Description
Customer reported: "from the very first post-operative period, the patient has always complained of pain and joint instability in the operated right knee.After evaluation at our clinics which confirmed the joint instability, on (b)(6) 2023 the patient underwent total prosthetic reimplantation.The removed prosthetic components appeared neat, with no marks or other mechanical complication.This report is sent with delay compared to the usual times due to computer error/(pre-filled report, but subsequently missing sending to the competent offices).Planting date (b)(6) 2022 (day not known).The report concerns the entire implantation of knee prostheses.".

• Brand Name: X3 TRIATHLON CS INS #8 13MM
• 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: 18859300
• Report Number: 0002249697-2024-00352
• Device Sequence Number: 3306472
• Product Code: MBH
• UDI-Device Identifier: 07613327046434
• UDI-Public: 07613327046434
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2024

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 Catalogue Number: 5531G813
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 39 YR
• Patient Sex: Unknown