MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INS SIZE1 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G109

Device Problem Unstable (1667)

Patient Problems Ambulation Difficulties (2544); Joint Laxity (4526)

Event Date 10/03/2023

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 5510f102: triathlon cr fem comp #1 r-cem: lot# unknown.Cat# 5550-g-278; triathlon symmetric x3 patella; lot# unknown.Cat# 5521-b-100; tri ts baseplate size 1; lot# unknown.Cat# 6197-9-001; simplex p with tobramycin 1 pack; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.

Event Description

Patient reported knee "collapses" and would like to know if parts are subject to a recall.

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 remains implanted.-clinician review: a review of medical records with a clinical consultant indicated this product inquiry concerns a patient who underwent a cemented total knee arthroplasty and is now complaining that the knee "collapses." the only way i can confirm that the patient had the knee replacement was by the documentation in the above implant record.It is unclear what this event actually is.The only symptom described is that the knee is "collapsing." this could describe a knee that is unstable or a knee that has a loose body within it or some other mechanical or soft tissue problem.Without more information the root cause of this issue cannot be determined.The root cause of instability is usually ligamentous of laxity which could be as a result of surgical technique factors, patient factors such as activity level in bmi and ligament integrity, and possibly implant factors.The implant itself could not be implicated as a causality unless there was any material defect in the implant.More information would be needed in 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 have been no other similar events for the lot referenced.Conclusions: a review of medical records with a clinical consultant indicated this product inquiry concerns a patient who underwent a cemented total knee arthroplasty and is now complaining that the knee "collapses." the only way i can confirm that the patient had the knee replacement was by the documentation in the above implant record.It is unclear what this event actually is.The only symptom described is that the knee is "collapsing." this could describe a knee that is unstable or a knee that has a loose body within it or some other mechanical or soft tissue problem.Without more information the root cause of this issue cannot be determined.The root cause of instability is usually ligamentous of laxity which could be as a result of surgical technique factors, patient factors such as activity level in bmi and ligament integrity, and possibly implant factors.The implant itself could not be implicated as a causality unless there was any material defect in the implant.More information would be needed in this case.[.] the patient would like to know if her implants are subject to a recall.A review indicated " no pfa's were found for the catalog number and lot combinations".No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient reported knee "collapses" and would like to know if parts are subject to a recall.

• Brand Name: X3 TRIATHLON CS INS SIZE1 9MM
• Type of Device: 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 NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 18009584
• MDR Text Key: 326554888
• Report Number: 0002249697-2023-01263
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327045581
• UDI-Public: 07613327045581
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 5531G109
• Device Lot Number: LFR037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 01/08/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 63 KG