MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5570-S-020

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

During revision, the nut was missing in the offset.

Manufacturer Narrative

An event regarding a missing component involving a triathlon adaptor was reported.The event was confirmed.The device was returned in new condition.It was confirmed the nut was missing in the offset.Medical records received and evaluation: not performed as medical records were not provided for review.A device history review confirmed all devices accepted into finished goods conformed to specification.There have been no other events for the lot referenced.This investigation exhibited a non conformance.Nc has been opened on (b)(6) 2018 to further investigate missing component.Due to the information and the historical nature of this isolated event, it cannot be definitively concluded that the problem occurred within stryker¿s control.It is unclear whether the issue occurred within or outside of stryker's control.No further investigation for this event is possible at this time.If additional information become available, this investigation will be reopened.

Event Description

During revision, the nut was missing in the offset.

• Brand Name: TRIATHLON TOTAL KNEE SYSTEM OFFSET ADAPTER 2MM
• 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: 7096491
• MDR Text Key: 94568934
• Report Number: 0002249697-2017-03506
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327014990
• UDI-Public: 07613327014990
• Combination Product (y/n): N
• PMA/PMN Number: K141056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2020
• Device Catalogue Number: 5570-S-020
• Device Lot Number: 0040305A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 01/24/2018
• Supplement Dates FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2015
• 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): Other