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

Model Number	5510-F-502
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding incorrect implant selection involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that a cemented femoral component was implanted when a press-fit implant was intended.The cemented femoral component was implanted without cement.Realization was made post-op and the patient's femoral component was revised the same day to a press-fit femoral component.The reported event was not confirmed as the patient implant sheets were not provided.Although not confirmed, the event is considered to be the result of user error as no manufacturing-related product problem was found given the information provided.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.H3 other text : not returned.
Event or Problem Description
The following was reported by the key accounts manager, who was not present for the surgery: primary procedure, right knee.It was reported that a cemented femoral component was implanted when a press-fit implant was intended.Additional information provided by the manager: surgeon's protocol is to implant a 'hybrid' knee construct with a cemented tibia and press-fit femur.Mps covering the case was not familiar with the surgeon or the surgeon's protocol and showed cemented components to the surgeon (with their assumption that all components would be cemented).Surgeon approved the implants (with his assumption that the tibia would be cemented and the femur would be press-fit).The cemented femoral component was implanted without cement.Realization was made post-op and the patient's femoral component was revised the same day to a press-fit femoral component.Manager confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: TRIATHLON CR FEM COMP #5 R-CEM
• Common Device Name: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17020728
• Report Number: 0002249697-2023-00600
• Device Sequence Number: 12550467
• Product Code: MBH
• UDI-Device Identifier: 07613327040302
• UDI-Public: 07613327040302
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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 Model Number: 5510-F-502
• Device Catalogue Number: 5510F502
• Device Lot Number: 9CR3U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female