MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS FEM COMP #7L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 5515F701

Device Problems Packaging Problem (3007); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Circulator discovered that the packaging was broken at outer packaging.Dr.Was not comfortable with sterilization of product and requested a new component.Update based on image provided- damaged flange of outer blister.

Manufacturer Narrative

An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed through visual inspection of the returned product.Method & results: device evaluation and results: visual inspection: on the unit carton, indentation lines are obvious on the sides and flap of the opening end on the inside and the outside.The carton is bulging on one side.The outer blister was returned with the tyvek lid removed.One side flange/lip of the outer blister was broken off the outer blister and remains attached to the tyvek lid.There is evidence of a good seal on the outer blister.The inner blister is sealed with the implant still inside, there is no evidence of damage to the inner blister.Medical records received and evaluation: not performed as the event is related to a packaging issue and no adverse consequences to the patient were reported.Device history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Based on the visual inspection of the returned product the investigation concluded that the packaging damage was most likely caused by incorrect/excessive handling prior to opening of the product whereby the unit carton may have been compressed and/or dropped from a height causing the damage to the carton.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

Circulator discovered that the packaging was broken at outer packaging.Dr.Was not comfortable with sterilization of product and requested a new component.Update based on image provided- damaged flange of outer blister.

• Brand Name: TRIATHLON PS FEM COMP #7L-CEM
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8073719
• MDR Text Key: 128398555
• Report Number: 0002249697-2018-03735
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 07613327040722
• UDI-Public: 07613327040722
• 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
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2023
• Device Catalogue Number: 5515F701
• Device Lot Number: DAR6H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other