MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 11MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5531-G-611-E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/30/2022
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.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.Not returned to the manufacturer.
Event or Problem Description
It was reported that the patient's knee was revised.Approximately 1 month post-implant, x-rays showed that the insert was not locked into the baseplate.A 6x11 cs insert was revised to a 6x10 cs insert.Rep can provide some additional information (refer to communications log), and confirmed that otherwise, no further information will be released by the hospital or surgeon.
Event or Problem Description
It was reported that the patient's knee was revised.Approximately 1 month post-implant, x-rays showed that the insert was not locked into the baseplate.A 6x11 cs insert was revised to a 6x10 cs insert.Rep can provide some additional information (refer to communications log), and confirmed that otherwise, no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding disassociation involving a triathlon insert was reported.The event was confirmed.Method & results: -product evaluation and results: visual inspection of the returned device indicated that the device is damaged in the area of the locking mechanism.Damage is consistent with explantation.-clinician review: a review of medical records with a clinical consultant indicated "this patient underwent a primary cementless left triathlon tritanium total knee arthroplasty.At some point, an x-ray was taken which showed improper placement of the polyethylene component with staples present.Subsequent to that another x-ray was taken with the staples removed and the polyethylene insert was still improperly placed.I have not been provided with any other information such as office notes, operation notes, etc.The causes of improper seating and/or placement of the polyethylene component are multifactorial.While i cannot confirm the root cause of this event with absolute certainty, in my opinion this is related to surgical technique.In the absence of any trauma or intervention, i have never seen a properly inserted polyethylene insert "pop out" in the immediate postoperative period.In many cases the poly must be impacted more than once in order to fully and properly seat.I would not assign any causality to the implant itself." -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: visual inspection of the returned device indicated that the device is damaged in the area of the locking mechanism.Damage is consistent with explantation.A review of medical records with a clinical consultant indicated "this patient underwent a primary cementless left triathlon tritanium total knee arthroplasty.At some point, an x-ray was taken which showed improper placement of the polyethylene component with staples present.Subsequent to that another x-ray was taken with the staples removed and the polyethylene insert was still improperly placed.I have not been provided with any other information such as office notes, operation notes, etc.The causes of improper seating and/or placement of the polyethylene component are multifactorial.While i cannot confirm the root cause of this event with absolute certainty, in my opinion this is related to surgical technique.In the absence of any trauma or intervention, i have never seen a properly inserted polyethylene insert "pop out" in the immediate postoperative period.In many cases the poly must be impacted more than once in order to fully and properly seat.I would not assign any causality to the implant itself." no further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: X3 TRIATHLON CS INSERT #6 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood, NJ WD6 3-SJ ; UK WD6 3SJ ; 2018315000
• MDR Report Key: 16213512
• Report Number: 0002249697-2023-00057
• Device Sequence Number: 19918774
• Product Code: MBH
• UDI-Device Identifier: 07613327337341
• UDI-Public: 07613327337341
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K172634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2023

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 Model Number: 5531-G-611-E
• Device Catalogue Number: 5531-G-611-E
• Device Lot Number: 3W3H86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male