MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6L; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5517F601

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Injury (2348)

Event Date 07/09/2019

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not returned.

Event Description

As reported: ".During the left total knee replacement a cruciate retaining femur was mistakenly opened and implanted instead of a posterior stabilized femur.This mistake went unnoticed until the patient was in post-op recovery.The patient was then returned to the operating room and the cruciate retaining femur was removed and the correct posterior stabilized femur was implanted".

Event Description

As reported: ".During the left total knee replacement a cruciate retaining femur was mistakenly opened and implanted instead of a posterior stabilized femur.This mistake went unnoticed until the patient was in post-op recovery.The patient was then returned to the operating room and the cruciate retaining femur was removed and the correct posterior stabilized femur was implanted.".

Manufacturer Narrative

An event regarding off label use involving a triathlon femoral component was reported.Conclusions: it was reported that during the left total knee replacement a cruciate retaining femur was mistakenly opened and implanted instead of a posterior stabilized femur.As per stryker surgical protocol a cruciate retaining femur can not be used in place of a posterior stabilized femur.Based on the provided information it has been determined that this event is associated with an off-label application.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: TRIATHLON P/A CR BEADED #6L
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8864277
• MDR Text Key: 153376480
• Report Number: 0002249697-2019-02751
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040975
• UDI-Public: 07613327040975
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 5517F601
• Device Lot Number: E946T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR