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
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/09/2019
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 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 or Problem 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 or Problem 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.".
Additional 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
• 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: 8864277
• Report Number: 0002249697-2019-02751
• Device Sequence Number: 262417
• Product Code: MBH
• UDI-Device Identifier: 07613327040975
• UDI-Public: 07613327040975
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 03/31/2024
• Device Catalogue Number: 5517F601
• Device Lot Number: E946T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 65 YR