MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5532-G-611
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Disability (2371)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding pain involving a triathlon insert was reported.The event was not confirmed.Method & results: product evaluation and results: not performed as the device was not returned.Medical records received and evaluation: not performed as no medical records were returned for review.Product history review: all 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 reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as evaluation of the device, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.The following devices were also listed in this report: triathlon p/a ps beaded #6r; cat# 5516f602; lot# byh9y; tritanium bplate triathlon s6; cat# 5536b600 ; lot# ctd16644; tritanium patella-asymmetric; cat# 5552-l-350 ; lot# d0ad.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
"procedure: patient underwent right total knee replacement (b)(6) 2017.Patient returned for pain and disability.Patient underwent revision on (b)(6) 2018 for suspicion of femoral component loosening (based on a bone scan), at surgery all components were found to be well fixed.Only poly was exchanged.".

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• 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: 7968835
• Report Number: 0002249697-2018-03361
• Device Sequence Number: 11156141
• Product Code: MBH
• UDI-Device Identifier: 07613327050851
• UDI-Public: 07613327050851
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 03/31/2022
• Device Catalogue Number: 5532-G-611
• Device Lot Number: MN0KA3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/16/2018
• 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: 64 YR
• Patient Weight: 113