MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #5 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number 5510-F-501

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  Injury  

Manufacturer Narrative

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.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.Device evaluated by manufacturer? not returned.

Event Description

Surgeon selected needed implants after trialing.I selected implants off the knee implant cart.There was a cemented femur implant on the cart where the corresponding cementless implant was designated.All implants were shown to the circulator and surgeon prior to being placed on the field.Cemented femur was implanted, rather than the intended cementless implant.The patient was brought back into the room, and the cemented implant was removed and replaced with the proper cementless implant.

Manufacturer Narrative

Reported event an event regarding incorrect selection involving a triathlon femoral component was reported.The event was confirmed via review of the provided implant sheet.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: it was reported a cemented implant was implanted, rather than the intended cementless implant.Provided implant sheet was reviewed and confirmed that the reported device (catalog # 5510-f-501) was implanted without bone cement.The reported event was confirmed.It was also reported that the incorrect implant was shown to the circulator and surgeon prior to being placed on the field.It was an user error that the incorrect implant was used.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.Device not returned.

Event Description

Surgeon selected needed implants after trialing.I selected implants off the knee implant cart.There was a cemented femur implant on the cart where the corresponding cementless implant was designated.All implants were shown to the circulator and surgeon prior to being placed on the field.Cemented femur was implanted, rather than the intended cementless implant.The patient was brought back into the room, and the cemented implant was removed and replaced with the proper cementless implant.

• Brand Name: TRIATHLON CR FEM COMP #5 L-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: 10761646
• MDR Text Key: 213846901
• Report Number: 0002249697-2020-02283
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040296
• UDI-Public: 07613327040296
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 5510-F-501
• Device Catalogue Number: 5510F501
• Device Lot Number: BE97E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR