MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-211
Medical Device Problem Codes	Loss of Osseointegration (2408); Noise, Audible (3273)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Patient reported joint loosening and audible noise following primary triathlon left knee surgery.Patient stated that symptoms started "immediately" following the (b)(6) 2020 surgery and that the knee was "never good".Patient stated she feels the loosening and did not state whether her surgeon confirmed the loosening.Patient stated that the joint noise is heard when she moves her "toes up and down".
Event or Problem Description
Patient reported joint loosening and audible noise following primary triathlon left knee surgery.Patient stated that symptoms started "immediately" following the february 2020 surgery and that the knee was"never good".Patient stated she feels the loosening and did not state whether her surgeon confirmed the loosening.Patient stated that the joint noise is heard when she moves her "toes up and down".
Additional Manufacturer Narrative
An event regarding femoral loosening involving a triathlon insert was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.During revision surgery, it is considered good surgical practice to always replace bearing components such as the tibial insert or hip liner including femoral head with new devices, also because service life damage or wear is not always readily visible and these components are usually modular and removal is easy and straightforward.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Patient would like to know if her implants were involved in a recall.It was confirmed that this device was not recalled.

• Brand Name: X3 TRIATHLON CS INSERT #2 11MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16640579
• Report Number: 0002249697-2023-00325
• Device Sequence Number: 12286317
• Product Code: MBH
• UDI-Device Identifier: 07613327045666
• UDI-Public: 07613327045666
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 01/03/2024
• Device Model Number: 5531-G-211
• Device Catalogue Number: 5531G211
• Device Lot Number: LHX367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• 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: Other
• Patient Sex: Female