MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #4L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5516-F-401
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
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 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.
Event or Problem Description
On (b)(6) 2021, three joint replacements were scheduled on the day tha>bilateral total knee (left knee first, then right knee).The incident happened during the right leg in the bilateral total knee case.During the case, 2 tka certified mps are present and followed the standard mako procedure.For this case, triathlon cr implants were initially planned; due to patient pathology, the surgeon decided to change to ps cementless implants.The circulating nurses provided the ps implants and have confirmed with the surgeon.No staffs were aware the femur implant is the left side instead of the right side.The surgeon then followed the standard procedure for implantation, and mako recorded the final leg tracking.The case was revised on (b)(6) 2021 by the surgeon.The wrong left ps femur implant was changed to a right ps cemented femur.During the case, for better femur access, the same ps insert was also exchanged.

• Brand Name: TRIATHLON P/A PS BEADED #4L
• 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: 11818159
• Report Number: 0002249697-2021-00846
• Device Sequence Number: 3792900
• Product Code: MBH
• UDI-Device Identifier: 07613327040814
• UDI-Public: 07613327040814
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2021

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: 09/30/2023
• Device Model Number: 5516-F-401
• Device Catalogue Number: 5516F401
• Device Lot Number: EER7E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 05/13/2021
• 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: Hospitalization; Required Intervention