MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR INSERT X3 #1 RM/LL -8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 5630-G-128

Device Problems Fitting Problem (2183); Insufficient Information (3190)

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

Event Date 01/17/2017

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.

Event Description

During triathlon pkr surgery, the insert did not fit to the tibial component.The surgeon hit it with a hammer.Then the tibia of the patient fractured.The revision surgery to tka is planned on (b)(6) 2017.

Manufacturer Narrative

An event regarding intraop fracture issue involving a triathlon insert was reported.The event was not confirmed.Method & results: device evaluation and results: visual, dimensional, and functional inspection were not performed as the item was not returned.Medical records received and evaluation: not performed as medical records were not provided.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review found no other events have been reported for the reported manufacturing lot.Conclusions: the event reported that the surgeon hit the insert with a hammer as insert did not fit to the tibial component.This resulted in a fracture in the tibia of the patient.The event could not be confirmed nor the root cause determined as insufficient information was not provided.Further information such as return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

During triathlon pkr surgery, the insert did not fit to the tibial component.The surgeon hit it with a hammer.Then the tibia of the patient fractured.The revision surgery to tka is planned on (b)(6) 2017.

• Brand Name: TRIATHLON PKR INSERT X3 #1 RM/LL -8MM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6329669
• MDR Text Key: 67386301
• Report Number: 0002249697-2017-00558
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 5630-G-128
• Device Lot Number: 4N5V58
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• 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
• Patient Age: 88 YR
• Patient Weight: 55