MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the product history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the lot referenced.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.Device not available.
Event or Problem Description
This pi is for the right knee.As reported in pi (b)(4): it was reported by the sale rep that the hcp is concerned over a/p instability & anterior subluxation of femur using cs insert after the primary surgery.Refer photo in intake tab.Patient function is normal.Primary surgery : (b)(6) 2019.Patient has not been revised as of the time of creation of this pi.In response to follow-up for pi (b)(4), a usage sheet was provided and no further information is available as it is being held by the hospital.
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: visual, dimensional, functional and material analysis could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant stated the following comment: this represents a 57 y/o male for whom no demographics, clinical or past medical history.Operative reports or follow-up or examination results are offered.The event description alludes to a tka on (b)(6) 2019 with a complaint of a-p instability and anterior subluxation of the femur post implantation of a cs insert.Listing of an 11 and 13 cs insert is noted.No operative reports, no x-rays and a statement "patient function is normal" is offered.Three photos - unlabeled and undated - show 2 lateral and 1 ap view of the left knee with a well healed recent anterior longitudinal knee incision.No gross pathology is noted on these photos.Based upon the information offered, no confirmation or explanation of the event description is possible and no report would be meaningful.Device history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the hcp was concerned over a/p instability & anterior subluxation of femur using cs insert after the primary surgery.The photographs provided were reviewed by a consulting clinician which were deemed insufficient to confirm the event.Further information such as x-rays, primary operative report, patient follow up notes and more patient history are required to complete this investigation.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for the right knee.As reported in pi (b)(4): it was reported by the sale rep that the hcp is concerned over a/p instability & anterior subluxation of femur using cs insert after the primary surgery.Refer photo in intake tab.Patient function is normal.Primary surgery : (b)(6) 2019.Patient has not been revised as of the time of creation of this pi.In response to follow-up for pi (b)(4), a usage sheet was provided and no further information is available as it is being held by the hospital.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• 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: 8913409
• Report Number: 0002249697-2019-02926
• Device Sequence Number: 10875113
• Product Code: MBH
• UDI-Device Identifier: 07613327045888
• UDI-Public: 07613327045888
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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: 04/30/2021
• Device Catalogue Number: 5531G513
• Device Lot Number: LEZ208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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: Other
• Patient Age: 57 YR