Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR FEM COMP #7 L-CEM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5510F701
Device Problem Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2019
Event Type  malfunction  
Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
 
Event Description
During a total knee replacement, the surgeon was preparing to implant the triathlon knee components.The femoral implant in question was opened outside the sterile field.As the surgeon was about to accept the implant he noticed that one of inner hard plastic packaging shells was damaged and therefore he was concerned the product may be unsterile.Every other aspect of product packaging seemed intact.The rim of the plastic shell wasn¿t complete all the way around, it looks like one side snapped away at some stage.This piece of plastic wasn¿t within the packaging anywhere.Surgeon did not take the product into the sterile field as a result, and a replacement part was taken from the consignment shelf and used and the procedure was completed as normal.
 
Manufacturer Narrative
An event regarding pack damage involving a triathlon femoral component was reported.The event was confirmed by the photograph.Method & results product evaluation and results: the reported device package was not received by pac however a photograph was provided for review.The photograph shows an opened carton, an opened outer blister and an inner blister package not opened.The tyvek layer of the outer blister package was removed and not shown in the picture.One side edge of the outer blister was fractured from the blister.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as evaluation of the device package is needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If the device package and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
During a total knee replacement, the surgeon was preparing to implant the triathlon knee components.The femoral implant in question was opened outside the sterile field.As the surgeon was about to accept the implant he noticed that one of inner hard plastic packaging shells was damaged and therefore he was concerned the product may be unsterile.Every other aspect of product packaging seemed intact.The rim of the plastic shell wasn¿t complete all the way around, it looks like one side snapped away at some stage.This piece of plastic wasn¿t within the packaging anywhere.Surgeon did not take the product into the sterile field as a result, and a replacement part was taken from the consignment shelf and used and the procedure was completed as normal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TRIATHLON CR FEM COMP #7 L-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 Key8503555
MDR Text Key141588860
Report Number0002249697-2019-01575
Device Sequence Number1
Product Code MBH
UDI-Device Identifier07613327040333
UDI-Public07613327040333
Combination Product (y/n)N
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Catalogue Number5510F701
Device Lot NumberDXC3N
Was Device Available for Evaluation? No
Date Manufacturer Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-