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
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/16/2013
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
It has been discovered that this pi is a duplicate of 2249697-2012-02077.Therefore, it will be cancelled.
Event or Problem 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
• Common Device Name: 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
• Report Number: 0002249697-2018-02274
• Device Sequence Number: 1065734
• Product Code: MBH
• UDI-Device Identifier: 07613327046021
• UDI-Public: 07613327046021
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K141056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

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