MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #2 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-209-E
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Ambulation or Postural Difficulties (2544); Swelling/ Edema (4577)
Date of Event	06/27/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Patient left voicemail reporting a primary knee implant less than 2 years ago using stryker triathlon knee and alleges swelling, stiffness & difficulty walking.Patient would like to know if implants are subject to a recall.Left knee.
Additional Manufacturer Narrative
An event regarding rom involving a triathlon insert was reported.The event was not confirmed, method & results: -device evaluation and results: material analysis, visual, dimensional and functional inspections were not performed as the device remains implanted.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation including the product inquiry summary, medical records related to a primary total knee including a discharge summary and operative note.An implant record was also reviewed.The event description from the product inquiries summary states: patient left voicemail reporting a primary knee implant less than 2 years ago using stryker triathlon knee and alleges swelling, stiffness & difficulty walking.Patient would like to know if implants are subject to a recall.The medical records and implant sheet confirm that the patient had a primary tka performed for advanced degenerative arthritis.No further information was available.The root cause for the patient's complaints can not be established from this limited information.Should additional information become available i would be happy to further this assessment.-device 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.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: i have had the opportunity to review documentation related to the product inquiry summary, medical records related to a primary total knee including a discharge summary and operative note.An implant record was also reviewed.The event description from the product inquiries summary states: patient left voicemail reporting a primary knee implant less than 2 years ago using stryker triathlon knee and alleges swelling, stiffness & difficulty walking.Patient would like to know if implants are subject to a recall.The medical records and implant sheet confirm that the patient had a primary tka performed for advanced degenerative arthritis.No further information was available.The root cause for the patient's complaints can not be established from this limited information.Should additional information become available i would be happy to further this assessment.It is noted that the patient is also inquiring if the device are subject to a recall.Based on the catalog and lot code provided the device reported is not subject to product recall.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.The following devices were also listed in this report: cat# 5510f201; triathlon cr fem comp #2 l-cem; lot# h242d.Cat# 5521-b-200; tri ts baseplate size 2; lot# e7r7za.Cat# 5551-g-299-e; triathlon asymmetric x3 patella; lot# 2vw3.Cat# 6191-1-001; simplex p full dose 1 pack; lot# rbb021.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 left voicemail reporting a primary knee implant less than 2 years ago using stryker triathlon knee and alleges swelling, stiffness & difficulty walking.Patient would like to know if implants are subject to a recall.Left knee.

• Brand Name: X3 TRIATHLON CS INSERT #2 9MM
• 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 NJ NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15050950
• Report Number: 0002249697-2022-01040
• Device Sequence Number: 5338655
• Product Code: MBH
• UDI-Device Identifier: 07613327336412
• UDI-Public: 07613327336412
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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: 02/28/2025
• Device Model Number: 5531-G-209-E
• Device Catalogue Number: 5531-G-209-E
• Device Lot Number: LJX351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2020
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 59 KG