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

Catalog Number 5620-B-301

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Injury (2348)

Event Date 09/07/2017

Event Type  Injury  

Manufacturer Narrative

Review of the product history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

The patient suffered a fall and sustained a fracture of the left lateral tibial condyle.The revision took place on (b)(6) 2017.The pkr device was revised to a cemented triathlon total knee.

Manufacturer Narrative

An event regarding periprosthetic fracture involving an triathlon femoral component was reported.The event was confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who deemed x-ray printouts available for review include a series dated (b)(6) 2014, which are multiple views, pre-operative, of the left knee demonstrating moderate osteoarthritic changes.X-rays dated (b)(6) 2014, described as ¿six weeks¿, are multiple views of the left knee demonstrating a cemented medial uka with the tibial component noted to have a 10° posterior slope.X-rays dated (b)(6) 2015 and (b)(6) 2016 are essentially unchanged with no evidence of pathology.Multiple views labeled ¿pre-op revision¿ are undated, but demonstrate no change in the medial uka, but a comminuted intraarticular fracture of the left lateral tibial plateau is noted.No examination of the explanted uka components is available for review.There is no evidence that the asymptomatic, well-functioning left medial uka components were responsible for the left knee trauma requiring conversion to a total knee arthroplasty." device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the event was confirmed and the medical review noted the trauma (patient fall) led to a revision surgery.The provided medical information was submitted to a consulting clinician who noted " x-rays dated (b)(6) 2015 and (b)(6) 2016 are essentially unchanged with no evidence of pathology.Multiple views labeled ¿pre-op revision¿ are undated, but demonstrate no change in the medial uka, but a comminuted intraarticular fracture of the left lateral tibial plateau is noted.No examination of the explanted uka components is available for review.There is no evidence that the asymptomatic, well-functioning left medial uka components were responsible for the left knee trauma requiring conversion to a total knee arthroplasty." if the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

The patient suffered a fall and sustained a fracture of the left lateral tibial condyle.The revision took place on (b)(6) 2017.The pkr device was revised to a cemented triathlon total knee.

• Brand Name: TRIATHLON PKR BASEPLATE #3 LM/RL
• 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: 6924776
• MDR Text Key: 88782162
• Report Number: 0002249697-2017-02934
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2018
• Device Catalogue Number: 5620-B-301
• Device Lot Number: IGZWA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2013
• 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
• Patient Age: 62 YR
• Patient Weight: 68