MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5532-G-619

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Sepsis (2067); Injury (2348)

Event Date 07/22/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the surgeon performed a bilateral revision on a patient's right knee, due to the presence of sepsis and cellulitis.Rep reports "incision drainage where triathlon poly were replaced".

Manufacturer Narrative

An event regarding revision due to suspected infection involving a triathlon insert was reported.The event was not confirmed.Material analysis is not performed as infection is not related to material integrity issue.Examination with material analysis engineer indicated explantation damage was observed on the insert.No medical records or x-rays were made available for evaluation.All devices in the reported lot were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot and sterile lot.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If additional information is received, this investigation will be reopened and re-evaluated.

Event Description

It was reported that the surgeon performed a bilateral revision on a patient's right knee, due to the presence of sepsis and cellulitis.Rep reports "incision drainage where triathlon poly were replaced".

• Brand Name: TRIATHLON PS X3 TIBIAL INSERT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: 6802408
• MDR Text Key: 82979326
• Report Number: 0002249697-2017-02520
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141056
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2012
• Device Catalogue Number: 5532-G-619
• Device Lot Number: EE5MKD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2007
• 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: 61 YR
• Patient Weight: 133