MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5517F602
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2019
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 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.Device not returned.
Event or Problem Description
As reported: "mako mps opened a cr femur and it was implanted on a ps prepped femur with a ps insert.I noticed when i was looking at paperwork the next day and went straight to doctor's clinic to notify him.Revision was done two days post original surgery".
Additional Manufacturer Narrative
Correction: expiration date.An event regarding use outside of indication of a trident femoral component was reported.Conclusion: based on the provided information it has been determined that this event is associated with an off-label application.The instructions for use for triathlon femoral components, ref (b)(4).Rev (b)(4).States: utilization and implantation: consult the product label for specific product compatibility.Generally, the following applies: use cr femorals only with cr or cs tibial bearings.No further investigation is required at this time.
Event or Problem Description
As reported: "mako mps opened a cr femur and it was implanted on a ps prepped femur with a ps insert.I noticed when i was looking at paperwork the next day and went straight to doctor's clinic to notify him.Revision was done two days post original surgery".Update (b)(6) 2019 wg: as reported by the h.R.Business partner: spoke to mps.Mps reported he pulled the implant box from the cart and handed it to the surgical staff without opening it.

• Brand Name: TRIATHLON P/A CR BEADED #6R
• 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: 8688326
• Report Number: 0002249697-2019-02231
• Device Sequence Number: 11572406
• Product Code: MBH
• UDI-Device Identifier: 07613327040999
• UDI-Public: 07613327040999
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/01/2019

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: 11/30/2023
• Device Catalogue Number: 5517F602
• Device Lot Number: ESA3R1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/05/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/01/2019
• 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: 58 YR