MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CS NUM6 10MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531-G-610-E

Device Problem Unstable (1667)

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 02/21/2024

Event Type  Injury  

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.Device not returned to the manufacturer.

Event Description

As reported: "on (b)(6) 2024 we were scheduled for a retinacular repair and i&d of a right total knee arthroplasty.Upon exposure to the joint, dr.Noticed that the 6x10 tibia insert was "rocking" in the tibial tray.After inspection of the insert, it appeared as if it was correctly engaged to the tibial baseplate, however was still rocking posteriorly.We took note of this and assumed that soft tissue was preventing the tibial insert from fully locking into the baseplate.We proceeded forward with the explant of the device, upon which dr.Examined the explanted 6x10 insert.Here, he noticed two "bevels on the posterior aspects of the tibial insert.He expressed his concerns that he thought something wasn't correct.He continued with his soft tissue work, i&d, and we proceeded to trial for a new poly.Once we chose our new cs poly, he compared the two on the back table.It was here that we noticed a difference in the two implants.The new 6x12 cs insert did not have the "bevels" posteriorly like the explanted 6x10 cs did.We thought maybe it was damaged when initially implanted but the bevels were oddly symmetric on both the medial and lateral aspect of the implant.Upon implantation of the new 6x12 cs insert, the poly was stable and the proceeded to close.He believes the unstable 6x10 poly caused the patient pain/instability)." rep confirmed only the insert was revised.Surgeon would like to know if this issue has been reported previously.

• Brand Name: X3 TRIATHLON INSERT CS NUM6 10MM
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18892998
• MDR Text Key: 337516545
• Report Number: 0002249697-2024-00392
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327390575
• UDI-Public: 07613327390575
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173849
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5531-G-610-E
• Device Lot Number: LH8KP9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male