MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #7 16MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5531G716

Device Problem Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 01/16/2013

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicates 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.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

Patient's wife called stating her husband had a stryker total knee implanted in 2014.10 months post-implant, knee was revised due to a damaged poly insert (patient's wife reported the device was "torn up" and "in chunks").Patient's wife specified implant took place (b)(6) 2012, revision (b)(6 2013.

Manufacturer Narrative

It has been discovered that this pi is a duplicate of 2249697-2012-02077.Therefore, it will be cancelled.

Event Description

Patient's wife called stating her husband had a stryker total knee implanted in 2014.10 months post-implant, knee was revised due to a damaged poly insert (patient's wife reported the device was "torn up" and "in chunks").Patient's wife specified implant took place (b)(6)2012 revision (b)(6)2013.

• Brand Name: X3 TRIATHLON CS INSERT #7 16MM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7714022
• MDR Text Key: 114834960
• Report Number: 0002249697-2018-02274
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327046021
• UDI-Public: 07613327046021
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 5531G716
• Device Lot Number: LCS746
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 98