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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

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STRYKER ORTHOPAEDICS-MAHWAH MRH KNEE FEM S LFT PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64811110
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Information (3190)
Event Date 04/24/2017
Event Type  malfunction  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation. Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced.
 
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".
 
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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
sarah smelko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6583532
MDR Text Key75720067
Report Number0002249697-2017-01602
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
Report Date 05/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Catalogue Number64811110
Device Lot NumberBAP6N
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/30/2016
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: 05/22/2017 Patient Sequence Number: 1
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