• 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 MRH KNEE FEM S LFT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

  • 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 MRH KNEE FEM S LFT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6481-1-110
Device Problems Device Damaged Prior to Use (2284); Contamination of Device Ingredient or Reagent (2901); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
An event regarding white residue involving a mrh femoral component was reported. The event was confirmed. Method & results: device evaluation and results: a visual inspection was carried out on the returned device a white residue was observed on the tray. A sample was taken from the tray for in-house analysis. The device was otherwise unremarkable. A material analysis was performed on the returned device which indicated that a review of modular rotating hinge knee femoral component, catalogue# 6481-1-110, lot code alk9r and inner blister plastic tray confirmed white particles on both tray and femoral. Characterisation using stereo microscopy and infrared spectroscopy confirmed particles as debris from petg inner blister tray due to mechanical abrasion with femoral component. Medical records received and evaluation: not performed as the reported device was not implanted. Device history review: the device was manufactured and accepted into final stock with no reported discrepancies. Complaint history review: there have been no other similar reported events for the lot referenced. Conclusions: the material analysis indicated that the inner blister plastic tray confirmed white particles on both tray and femoral. Characterisation using stereo microscopy and infrared spectroscopy confirmed particles as debris from petg inner blister tray due to mechanical abrasion with femoral component. The exact cause of the event could not be determined because no other packaging was returned. No further investigation is possible at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
 
Event Description
During a revision knee when it was time to open the implants the surgeon and rep in the room noticed a powder like substance on the femoral implant. They then opened two stems and both stems had the same residue. A second femoral implant was rushed to the hospital and once again was found to have the same residue on the implant. The surgeon was obviously very upset by this and had to soak the implants in betadine before finally implanting them as there were no other alternatives. These implants all came from "national loaners".
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
 
Event Description
During a revision knee when it was time to open the implants the surgeon and rep in the room noticed a powder like substance on the femoral implant. They then opened two stems and both stems had the same residue. A second femoral implant was rushed to the hospital and once again was found to have the same residue on the implant. The surgeon was obviously very upset by this and had to soak the implants in betadine before finally implanting them as there were no other alternatives. These implants all came from "national loaners".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMRH KNEE FEM S LFT
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER
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
cindy chuhinko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6579819
MDR Text Key206096146
Report Number0002249697-2017-01592
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model Number6481-1-110
Device Catalogue Number64811110
Device Lot NumberALK9R
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/19/2017 Patient Sequence Number: 1
-
-