MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #3 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-311
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	01/30/2020
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.
Event or Problem Description
The following was reported: i had a total knee replacement done and, have had major issues with it.The plastics were loose causing my knee to buckle, lock up, have excess side to side movement, constant pain in my left knee and, fell down stairs because of it.I had a revision surgery done on (b)(6) 2020, where the plastics were replaced.I have made multiple trips to my orthopedic doctor for severe pain in my knee before and after the second surgery with no avail.I am extremely unhappy with the results of the knee replacement and now, suffer nerve damage and constant extreme pain in my left knee.The pain in my knee is so severe that i can¿t sleep at night nor can i perform normal day to day activities.This report is for revision of the patient's left knee on (b)(6) 2020.
Event or Problem Description
The following was reported: i had a total knee replacement done and, have had major issues with it.The plastics were loose causing my knee to buckle, lock up, have excess side to side movement, constant pain in my left knee and, fell down stairs because of it.I had a revision surgery done on (b)(6) 2020, where the plastics were replaced.I have made multiple trips to my orthopedic doctor for severe pain in my knee before and after the second surgery with no avail.I am extremely unhappy with the results of the knee replacement and now, suffer nerve damage and constant extreme pain in my left knee.The pain in my knee is so severe that i can¿t sleep at night nor can i perform normal day to day activities.This report is for revision of the patient's left knee on (b)(6) 2020.
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: "the patient appeared to undergo a revision knee surgery with replacement of the polyethylene increasing the thickness to 16mm for complaints of pain and instability.No sound conclusions may be made due to the lack of medical records.Device or procedure related adverse event: no device related issues were apparent.Root cause and confirmation: a root cause cannot be determined due to a lack of medical information.A revision surgery can be confirmed." -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: it was reported that the patient's left knee was revised due to instability and pain: the insert was revised to a greater thickness.A review of the provided medical records by a clinical consultant indicated that "no sound conclusions may be made due to the lack of medical records" and "no device related issues were apparent." 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 or Problem Description
The following was reported: i had a total knee replacement done and, have had major issues with it.The plastics were loose causing my knee to buckle, lock up, have excess side to side movement, constant pain in my left knee and, fell down stairs because of it.I had a revision surgery done on (b)(6) 2020, where the plastics were replaced.I have made multiple trips to my orthopedic doctor for severe pain in my knee before and after the second surgery with no avail.I am extremely unhappy with the results of the knee replacement and now, suffer nerve damage and constant extreme pain in my left knee.The pain in my knee is so severe that i can¿t sleep at night nor can i perform normal day to day activities.This report is for revision of the patient's left knee on (b)(6) 2020.Patient would like to know if x3 insert subject to a recall.
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: "the patient appeared to undergo a revision knee surgery with replacement of the polyethylene increasing the thickness to 16mm for complaints of pain and instability.No sound conclusions may be made due to the lack of medical records.Device or procedure related adverse event: no device related issues were apparent.Root cause and confirmation: a root cause cannot be determined due to a lack of medical information.A revision surgery can be confirmed." 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: it was reported that the patient's left knee was revised due to instability and pain: the insert was revised to a greater thickness.A review of the provided medical records by a clinical consultant indicated that "no sound conclusions may be made due to the lack of medical records" and "no device related issues were apparent." the patient is also enquiring if their implants are subject to recall.A search indicated that the subject device is not part of a recall.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.

• Brand Name: X3 TRIATHLON CS INSERT #3 11MM
• 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: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 15392924
• Report Number: 0002249697-2022-01315
• Device Sequence Number: 17369832
• Product Code: MBH
• UDI-Device Identifier: 07613327045734
• UDI-Public: 07613327045734
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K063423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2022
• Device Model Number: 5531-G-311
• Device Catalogue Number: 5531G311
• Device Lot Number: LFY901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 12/28/2022; 05/03/2024
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 01/19/2023; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 70 KG