MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-609
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Inflammation (1932); Joint Laxity (4526)
Date of Event	11/25/2020
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 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.Device not returned.
Event or Problem Description
Patient presented 14 months post left total knee replacement with an effusion and swelling.The swabs showed no infection.The dr scoped the knee, where he discovered that the poly tibial insert appeared loose.He is planning to revise the poly in late (b)(6) or (b)(6) 2021.
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: a review of the provided medical information by a clinical consultant indicated: re pi - 2564819 which is from australia and states a date of implantation as (b)(6) 2019.The event description states: ".14 months post left total knee replacement with an effusion and swelling.Swabs showed no infection.Scoped knee.Tibial insert appeared loose.Planning to revise poly."(b)(6) 2019 handwritten "surgeon;s report" poorly legible "oa left knee" "9 mm cs insert" uncomplicated left tha described.No clinical or pmh, no patient demographics, no imaging studies, no evidence revision surgery indicated or performed.Based upon the information available for review, neither confirmation of the event description nor preparation of a medical report is possible for this case.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 has been 1 other similar events for the lot referenced.The pi relates to instability.Conclusions: the event could not be confirmed as insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, primary 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient presented 14 months post left total knee replacement with an effusion and swelling.The swabs showed no infection.The dr scoped the knee, where he discovered that the poly tibial insert appeared loose.He is planning to revise the poly in late (b)(6) 2021.

• Brand Name: X3 TRIATHLON CS INSERT #6 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
• MDR Report Key: 11043058
• Report Number: 0002249697-2020-02713
• Device Sequence Number: 19091226
• Product Code: MBH
• UDI-Device Identifier: 07613327045932
• UDI-Public: 07613327045932
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2021

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: 06/30/2024
• Device Model Number: 5531-G-609
• Device Catalogue Number: 5531G609
• Device Lot Number: LJF713
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 12/20/2020
• Supplement Report FDA Received Date: 08/18/2021
• 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