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

Model Number	5530-G-309-E
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's left knee was revised due to pain and instability.Surgeon originally planned to revise a 3x9 cs insert with a 3x12 cs insert.However, intra-operatively the surgeon decided to convert the patient to a ps construct and revised the femur as well.
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.Catalog numbers and lot codes of other devices listed in this report: 5510f301 triathlon cr fem comp #3 l-cem, lot jyj2e.6191-1-001 simplex p full dose 1 pack, lot rgb042.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Reported event: an event regarding instability 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 indicated: conclusion/assessment: a patient underwent a tka and an mua.Instability of the knee was diagnosed as well as advance hip arthritis at approximately 1 year follow-up.A revision tka was recommended.The procedure was apparently performed but this was only documented in the pi report.Event confirmation: a primary tka, mua and an exam with instability could be confirmed.A revision tka could not be confirmed root cause: the root cause of the proposed revision was knee instability.But the event was not confirmed.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 indicated: conclusion/assessment: a patient underwent a tka and an mua.Instability of the knee was diagnosed as well as advance hip arthritis at approximately 1 year follow-up.A revision tka was recommended.The procedure was apparently performed but this was only documented in the pi report.Event confirmation: a primary tka, mua and an exam with instability could be confirmed.A revision tka could not be confirmed root cause: the root cause of the proposed revision was knee instability.But the event was not confirmed.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
It was reported that the patient's left knee was revised due to pain and instability.Surgeon originally planned to revise a 3x9 cs insert with a 3x12 cs insert.However, intra-operatively the surgeon decided to convert the patient to a ps construct and revised the femur as well.

• Brand Name: TRIATHLON CR X3 TIBIAL INSERT
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16403316
• Report Number: 0002249697-2023-00169
• Device Sequence Number: 14860761
• Product Code: MBH
• UDI-Device Identifier: 07613327382716
• UDI-Public: 07613327382716
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 08/31/2025
• Device Model Number: 5530-G-309-E
• Device Catalogue Number: 5530-G-309-E
• Device Lot Number: TJ28JM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2020
• 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: Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 68 KG