MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #3 R-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-302

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

It was reported that on (b)(6) 2019 a cemented cr femoral component was implanted without cement.No stryker rep was present for the procedure.Discovery was made (b)(6) 2019 when the rep noted an inventory discrepancy.Further investigation identified the case in which the component was used, and the fact that no cement was used.The surgeon was notified and the patient was revised on (b)(6) 2019.Rep provided the primary usage sheet and reported that no further information will be available.

Manufacturer Narrative

An event regarding revision due to user error involving a triathlon femoral component was reported.The event was confirmed based on provided implant sheet and label review.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: a review of the most recent version of the ifu noted that "components labeled for ¿cemented use only¿ are to be implanted only with bone cement." a review of the label design for part 5510-f-302 was completed and noted that the following statement is referenced on the label: "warning: this device is intended for cemented use only".It was reported that the surgeon implanted this device without cement, which did not follow the instructions in ifu and product label.Thus, this event is determined to be caused due to user error.No further investigation for this event is required at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

It was reported that on (b)(6) 2019 a cemented cr femoral component was implanted without cement.No stryker rep was present for the procedure.Discovery was made (b)(6) 2019 when the rep noted an inventory discrepancy.Further investigation identified the case in which the component was used, and the fact that no cement was used.The surgeon was notified and the patient was revised on (b)(6) 2019.Rep provided the primary usage sheet and reported that no further information will be available.

• Brand Name: TRIATHLON CR FEM COMP #3 R-CEM
• 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: 9412274
• MDR Text Key: 169210244
• Report Number: 0002249697-2019-03941
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040265
• UDI-Public: 07613327040265
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 5510-F-302
• Device Catalogue Number: 5510F302
• Device Lot Number: DTJ7B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR