MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PKR FEMUR #6 RM/LL; IMPLANT

Catalog Number 5610-F-602

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/18/2014

Event Type  malfunction  

Event Description

Upon opening the pkr size 6 rm implant a small hole was noticed in the both blister pack covers.The issue was brought to the surgeons attention and the decision was made to use the next size down implant.

Manufacturer Narrative

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

Manufacturer Narrative

Device history review: review of the device history records indicate devices were manufactured and accepted into final stock.Complaint history review: there have been no other events reported for the reported manufacturing lot.Visual inspection: the implant was received in the carton with the shrink wrap ripped at the top from the user opening the box.Slight compression damage was noted to one of the sides of the carton.A loaners sticker is present on the other side of the carton, applied to the shrink wrap.The outer blister and inner blister were both in tact and fully sealed.No signs of any attempts to open the outer blister pack were noted.The implant was oriented in the upper right corner with the pegs facing upward.A hole was observed in the upper right corner of the outer tyvek lid.The outer blister was then opened and a hole, respective to the implant position and hole in the outer lid, was observed in the inner tyvek lid.The inner tyvek lid was opened, and further damage to the tyvek around the hole was observed.White particles were observed on the surface of the implant.This is assumed to be a result of the grit-blasted internal surfaces and pegs rubbing up against the foam.Dimensional and functional inspections were not performed as the reported event relates to a packaging issue.The event was confirmed.The packaging was confirmed to be assembled per specification.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Upon opening the pkr size 6 rm implant a small hole was noticed in the both blister pack covers.The issue was brought to the surgeons attention and the decision was made to use the next size down implant.

• Brand Name: TRIATHLON PKR FEMUR #6 RM/LL
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3674431
• MDR Text Key: 19568269
• Report Number: 0002249697-2014-00746
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 5610-F-602
• Device Lot Number: DKXFR1
• Other Device ID Number: STERILE LOT# MSHKT05A3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2011
• 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 Age: 67 YR
• Patient Weight: 94