MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515-F-502

Device Problems Difficult to Open or Remove Packaging Material (2922); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Triathlon #5 right ps femoral implant stuck in packaging while doing a right total knee.

Manufacturer Narrative

An event regarding a packaging issue involving a triathlon femoral component was reported.The event was not confirmed.Method & results: -device evaluation and results: the femoral component packaging with shrink wrap opened and the opened outer and inner blister were returned.The outer blister tyvek was returned removed from blister and folded in packaging box.The plastic tray was returned.The foam was not returned.The inner blister tyvek was not returned.The femoral component was not returned.-medical records received and evaluation: the event is not related to patient factors.-device history review: review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for this lot.Conclusions: the event was not confirmed as the femoral component, foam and inner blister tyvek was not returned.However, there is a known packaging issue where the foam gets stuck to the tyvek lid upon attempt to open.Packaging innovations is aware of this, and has issued a memo.

Event Description

Triathlon #5 right ps femoral implant stuck in packaging while doing a right total knee.

• Brand Name: TRIATHLON PS FEM COMPONENT, CEMENTED
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5761057
• MDR Text Key: 49279722
• Report Number: 0002249697-2016-02122
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 5515-F-502
• Device Lot Number: UDYOUHGR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2016
• 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
• Patient Age: 58 YR
• Patient Weight: 106