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

Catalog Number	5517F402
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding instability involving a triathlon femoral component was reported.Medical review of the provided medical records confirms malposition of the femoral component.Method & results: -device evaluation and results: not performed as the femoral component was not returned, it remains implanted.-medical records received and evaluation: the medical review indicated femoral component malposition in posterior position plus excessive distal femoral bone resection in combination with baseplate malposition in excessive posterior slope of 11° has contributed to complex and global knee instability with pain symptoms requiring revision.-device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: complaint history review confirmed that there have been no other similar events for the reported lot.Conclusions: a review of the provided medical records by a clinical consultant indicated the medical review indicated femoral component malposition in posterior position plus excessive distal femoral bone resection in combination with baseplate malposition in excessive posterior slope of 11° has contributed to complex and global knee instability with pain symptoms requiring revision.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Not returned.
Event or Problem Description
Patient visit out clinic with pain and instability.Update: based on the medical review - femoral component malposition in posterior position plus excessive distal femoral bone resection in combination with baseplate malposition in excessive posterior slope of 11° has contributed to complex and global knee instability with pain symptoms requiring revision.

• 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: 7406183
• Report Number: 0002249697-2018-01051
• Device Sequence Number: 13958902
• Product Code: MBH
• UDI-Device Identifier: 07613327040944
• UDI-Public: 07613327040944
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2018

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: 11/30/2020
• Device Catalogue Number: 5517F402
• Device Lot Number: ADE8S3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/09/2018
• 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: 66 YR