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 Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no revelant discrepancies.There have been 1 other similar events for the lot referenced.

Event Description

Implanted the triathlon for okr procedure on (b)(6) 2017.The tibia side bone became a fracture and it will be treated on (b)(6) 2017.

Manufacturer Narrative

Lot code updated to unknown.An event regarding periprosthetic fracture involving a triathlon baseplate was reported.The event was not confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.No medical records or x-rays were made available for evaluation.A review of the device history records could not be performed as no lot information was provided.A complaint history review could not be performed as no lot information was provided.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Implanted the triathlon for okr procedure on (b)(6) 2017.The tibia side bone became a fracture and it will be treated on (b)(6) 2017.

• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6631956
• MDR Text Key: 77273275
• Report Number: 0002249697-2017-01807
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• 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,Followup
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2018
• 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: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2013
• 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): Hospitalization; Required Intervention