MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS #2 12MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	5531-G-212-E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.An event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: no patient demographics, no clinical or pmh, no operative reports, no imaging studies, no exam of explanted components.Based upon the information available for review, no determination can be made regarding the cause of this clinical event, and a meaningful medical report is not possible.Additional documentation is implant labels from primary left tka on (b)(6) 2019 which include triathlon products: #3 left cr fem.Component, #2 primary tib.Baseplate, #2/12 x3 cs insert, 31/9 symmetric x3 patella.Device history review: all 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 reported lot.Conclusion: a review of the provided medical records by a clinical consultant stated the following comment: no patient demographics, no clinical or pmh, no operative reports, no imaging studies, no exam of explanted components.Based upon the information available for review, no determination can be made regarding the cause of this clinical event, and a meaningful medical report is not possible.Additional documentation is implant labels from primary left tka on (b)(6) 2019 which include triathlon products: #3 left cr fem.Component, #2 primary tib.Baseplate, #2/12 x3 cs insert, 31/9 symmetric x3 patella.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: triathlon cr fem comp #3 l-cem; cat# 5510f301; lot# hat6n.Triathlon prim cem fxd bplt #2; cat# 5520b200; lot# e4x4c.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that the patient's left knee was revised.As reported: "riding exercise bike and felt a tear had 'vigorous pain'." the patient's entire left total knee construct was revised.Rep provided surgeon notes, office notes, and a primary operative report for the patient's other (right) knee, and reported that no further information will be released by the hospital or surgeon.

• Brand Name: X3 TRIATHLON INSERT CS #2 12MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9954274
• Report Number: 0002249697-2020-00735
• Device Sequence Number: 2808688
• Product Code: JWH
• UDI-Device Identifier: 07613327391596
• UDI-Public: 07613327391596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173849
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2020

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: 11/30/2023
• Device Model Number: 5531-G-212-E
• Device Catalogue Number: 5531-G-212-E
• Device Lot Number: W7521V
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 67 YR