MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #5 13MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number	5531G513
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	11/25/2013
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 reported discrepancies.There have been no other events for the lot referenced.The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.The following devices were also listed in this report: triathlon mb patella pa a35; cat# 5554l350; lot# sxtyk.Triathlon prim bead pa sze5 bp; cat# 5526b500; lot# s4ccj.Triathlon p/a cr beaded #5r; cat# 5517f502; lot# s3ymc.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Device evaluated by mfr: not returned.
Event or Problem Description
This pi is for the right hip.It was reported through the communication of an attorney that allegedly the patient was revised due to "right knee pain, status post right total knee arthroplasty.".
Event or Problem Description
This pi is for the right hip.It was reported through the communication of an attorney that allegedly the patient was revised due to "right knee pain, status post right total knee arthroplasty.".
Additional Manufacturer Narrative
Based on information received, this patient only had a left tha revision; which is capture under mfr numbers 0002249697-2019-02506, 0002249697-2019-02507; 0002249697-2019-02508 and 0002249697-2019-02509.There is no evidence that the patient received righ tha; therefore, this record will be cancelled.

• Brand Name: X3 TRIATHLON CS INSERT #5 13MM
• 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: 8753509
• Report Number: 0002249697-2019-02497
• Device Sequence Number: 19314102
• Product Code: MBH
• UDI-Device Identifier: 07613327045888
• UDI-Public: 07613327045888
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 05/31/2016
• Device Catalogue Number: 5531G513
• Device Lot Number: LCJ673
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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: 52 YR