MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A PS BEADED #6R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5516F602

Device Problems Crack (1135); Delivered as Unsterile Product (1421); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

It was reported that during a primary right knee procedure, when staff opened the package and peeled off the blister, it was noticed that the inner tray containing the implant was cracked on edge.Sterility was questioned as a result and a new implant was opened and implanted.Case completed without delay or any adverse consequences to the patient or user.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection was completed on the returned outer blister, inner blister and device.The unit carton was not returned for review.The flange of the outer blister is cracked and broken on one side and is still attached to the tyvek lid.This type of damage would be consistent with a shock load, e.G.The carton being dropped from a height and/or compression however without visual inspection of the unit carton it is not possible to confirm this.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to opening of the packaging however visual inspection of the unit carton it is required to confirm this.No further investigation for this event is required at this time.

Event Description

It was reported that during a primary right knee procedure, when staff opened the package and peeled off the blister, it was noticed that the inner tray containing the implant was cracked on edge.Sterility was questioned as a result and a new implant was opened and implanted.Case completed without delay or any adverse consequences to the patient or user.

• Brand Name: TRIATHLON P/A PS BEADED #6R
• 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-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5477841
• MDR Text Key: 39808070
• Report Number: 0002249697-2016-00669
• 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: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 5516F602
• Device Lot Number: AAC6M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2015
• 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
• Patient Age: 74 YR