MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS TRIATHLON TRIAL TIBIAL INSERT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META

Model Number 5530-T-409B

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2017

Event Type  malfunction  

Event Description

During a total knee arthroplasty, the plastic trial insert broke.All the pieces were retrieved, and an x-ray was taken.The radiologist reported directly to the attending surgeon that the x-ray was negative.

• Brand Name: TRIATHLON TRIAL TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/META
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP AKA STRYKER ORTHOPAEDICS; 325 corporate dr.; mahwah NJ 07430
• MDR Report Key: 6356042
• MDR Text Key: 68232652
• Report Number: 6356042
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5530-T-409B
• Device Catalogue Number: 5530-T-409
• Device Lot Number: CE 0086
• Other Device ID Number: KMAWM5 REV D
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 82