MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problem Collapse (1099)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 02/16/2015

Event Type  Injury  

Event Description

Patient had triathlon cr knee replacement done on right knee in (b)(6) 2014.Patient fell in (b)(6) 2014 sustaining a tibial plateau fracture of his right knee.No surgical intervention to repair fracture, only wearing brace was prescribed.Patient still had pain and x-ray revealed collapse under tibial component.Revision surgery scheduled using triathlon ts system.

Manufacturer Narrative

Catalogue number unknown at this time.Device description reported as an unknown size 7 triathlon tibial tray.An evaluation of the device cannot be performed as the device and additional information were not made available to the manufacturer due to hospital policy.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4592692
• MDR Text Key: 5447223
• Report Number: 0002249697-2015-00695
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 122