MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR BASEPLATE #3 RM/LL; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5620-B-302

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Surgeon commented that patient had loose tibia component based on bone scan and pain.

• Brand Name: TRIATHLON PKR BASEPLATE #3 RM/LL
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 5355261
• MDR Text Key: 35492288
• Report Number: 0002249697-2016-00018
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 5620-B-302
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• 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