MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #4R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Model Number	5517-F-402
Medical Device Problem Codes	Off-Label Use (1494); Misassembly by Users (3133)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/27/2020
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 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 or Problem Description
It was reported that the patient's right mako tka was revised due to implantation of a cr femur in a knee prepped for ps.Rep was not present for the procedure.Intra-operatively, the femur was prepped and trialed for a ps implant.After the mps would have brought the implant to the or prior to the procedure, the device would have been shown to the circulating nurse, then to the surgical tech, and shown and handed to the surgeon or surgeon's pa.Upon billing of the case, the fact that the cr femur was implanted was brought to the surgeon's attention.The surgeon took x-rays on (b)(6) 2020 and confirmed a cr femur was in the patient.The patient was then revised.Rep provided the primary usage sheet and confirmed that no further information will be available.
Event or Problem Description
It was reported that the patient's right mako tka was revised due to implantation of a cr femur in a knee prepped for ps.Rep was not present for the procedure.Intra-operatively, the femur was prepped and trailed for a ps implant.After the mps would have brought the implant to the or prior to the procedure, the device would have been shown to the circulating nurse, then to the surgical tech, and shown and handed to the surgeon or surgeon's pa.Upon billing of the case, the fact that the cr femur was implanted was brought to the surgeon's attention.The surgeon took x-rays on (b)(6) 2020 and confirmed a cr femur was in the patient.The patient was then revised.Rep provided the primary usage sheet and confirmed that no further information will be available.
Additional Manufacturer Narrative
An event regarding incorrect selection ( knee prepped for ps femoral but implanted a cr femoral by mistake) was reported.Conclusion: the event indicates that right mako tka was revised due to implantation of a cr femur in a knee prepped for ps.Intra-operatively, the femur was prepped and trailed for a ps implant.After the mps would have brought the implant to the or prior to the procedure, the device would have been shown to the circulating nurse, then to the surgical tech, and shown and handed to the surgeon or surgeon's pa.Upon billing of the case, the fact that the cr femur was implanted was brought to the surgeon's attention.The surgeon took x-rays on (b)(6) 2020 and confirmed a cr femur was in the patient.The patient was revised on (b)(6) 2020.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 #4R
• 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: 9885061
• Report Number: 0002249697-2020-00610
• Device Sequence Number: 2784752
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

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: 12/31/2023
• Device Model Number: 5517-F-402
• Device Catalogue Number: 5517F402
• Device Lot Number: JJS7D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/23/2020
• 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: 69 YR
• Patient Weight: 68