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 PS FEM COMPONENT, CEMENTED; 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 PS FEM COMPONENT, CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO Back to Search Results
Catalog Number 5515-F-401
Device Problems Device Emits Odor (1425); Device Damaged Prior to Use (2284); Manufacturing, Packaging or Shipping Problem (2975); Moisture or Humidity Problem (2986)
Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348)
Event Date 12/03/2015
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
The customer reported that as they opened up the triathlon femoral component in theatre, they noticed that there was water or condensation in the inside of the inner box which smelled like sewage.The customer further reported that the plastic seal on the outside of the implant was still intact.The stryker sales representative reported that the device was out of a loan kit and as such the customer did not have any additional items on the shelf to continue the case.The stryker sales representative reported that she was able to get hold of another device from a neighboring hospital and that resulted in a 30 minute delay to surgery.Surgery was completed successfully.There were no adverse consequences for the patient.The stryker sales representative further reported that she had checked the kit 2 days before the case and there was no water in the kit at that time.The outer box of the implant appeared to be normal.
 
Manufacturer Narrative
An event regarding packaging damage involving a triathlon femoral component was reported.The event was confirmed.Method and results: device evaluation and results: based on the visual inspection of the returned packaging it appears that the packaging got soaking wet at some stage prior to surgery as condensation inside the the box and a sewage-like smell was noticed while opening the packaging in theatre.The unit carton has severe water damage and was still damp with an odour coming from the packaging when received in limerick for review but has since dried out.Both the outer and inner blister packaging appear to be intact.Upon opening of the inner packaging the device itself is unremarkable.Medical records received and evaluation: not performed as the event relates to a packaging issue.Other than a 30 minute delay in surgery, no further adverse consequences to the patient were reported.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.Complaint history review: chr review determined that there were no similar events reported for the lot.Conclusions: based on the visual inspection of the returned packaging and the information provided in the event description, it appears that the device packaging got soaking wet shortly before surgery as the stryker sales representative indicated that there was no water in the kit two days before the surgery and that the implant box appeared to be normal.Also, during surgery, condensation inside the the box and a sewage-like smell was noticed while opening the packaging.The unit carton was still damp with an odour coming from the packaging when received in limerick for review but has since dried out.The device would not have left the finished goods warehouse in this condition.No further investigation for this event is possible at this time.
 
Event Description
The customer reported that as they opened up the triathlon femoral component in theatre, they noticed that there was water or condensation in the inside of the inner box which smelled like sewage.The customer further reported that the plastic seal on the outside of the implant was still intact.The stryker sales representative reported that the device was out of a loan kit and as such the customer did not have any additional items on the shelf to continue the case.The stryker sales representative reported that she was able to get hold of another device from a neighboring hospital and that resulted in a 30 minute delay to surgery.Surgery was completed successfully.There were no adverse consequences for the patient.The stryker sales representative further reported that she had checked the kit 2 days before the case and there was no water in the kit at that time.The outer box of the implant appeared to be normal.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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-LIMERICK
raheen business park
limerick NA
Manufacturer Contact
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5314003
MDR Text Key34739226
Report Number0002249697-2015-04395
Device Sequence Number1
Product Code MBH
Combination Product (y/n)N
Reporter Country CodeGB
PMA/PMN Number
K141056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 12/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue Number5515-F-401
Device Lot NumberAFR4D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age61 YR
-
-