MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS NUM2 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531-G-210-E
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	04/29/2024
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.The following devices were also listed in this report: 5521-b-200, tri ts baseplate size 2, idx4db.5551-g-299.Triathlon asymmetric x3 patella, 4pnk.5510f201, triathlon cr fem comp #2 l-cem, n6a7n.Unknown bone cement: it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient reported they had a left knee mako robotic assisted procedure and noted having full flexion and extension, but reported experiencing pain, swelling, heat, and clicking.
Additional Manufacturer Narrative
An event regarding pain and audible noise involving a triathlon insert was reported.The events were not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.Clinician review: a review of the provided medical records by a clinical consultant indicated: "the operative reports and imaging reports confirm a left tka was performed.No clinical information was provided to document the presence of, and reasons for, the patients reported pain, swelling , heat and clicking." 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 is experiencing pain and clicking post-implantation.The operative reports and imaging reports confirm a left tka was performed.No clinical information was provided to document the presence of, and reasons for, the patients reported pain, swelling , heat and clicking.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: 5521-b-200, tri ts baseplate size 2 idx4db.5551-g-299, triathlon asymmetric x3 patella 4pnk.5510f201, triathlon cr fem comp #2 l-cem n6a7n.61941010, simplex hv us plain 10 pk 211af817ad.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
Patient reported they had a left knee mako robotic assisted procedure and noted having full flexion and extension, but reported experiencing pain, swelling, heat, and clicking.

• Brand Name: X3 TRIATHLON INSERT CS NUM2 10MM
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19356183
• Report Number: 0002249697-2024-00764
• Device Sequence Number: 6342240
• Product Code: MBH
• UDI-Device Identifier: 07613327391589
• UDI-Public: 07613327391589
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 5531-G-210-E
• Device Lot Number: YA18PT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2022
• 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: Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 59 KG