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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 11MM X 127MM FEMORAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRS 11MM X 127MM FEMORAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6485-3-011
Device Problem Osseointegration Problem (3003)
Patient Problem Inadequate Osseointegration (2646)
Event Date 08/04/2021
Event Type  Injury  
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. An evaluation of the device cannot be performed as the device was not returned to the manufacturer. Should additional information become available it will be reported in a supplemental report upon completion of the investigation. Not returned to the manufacturer.
 
Event Description
As reported: "pt. Presented with a loose cemented stem of a previous [right] gmrs distal-femur replacement on (b)(6) 2020. Dr revised the femoral components to the implants on the sheet below. " spoke to rep: there are no allegations against any other devices. No further information will be released by the hospital or surgeon.
 
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Brand NameMRS 11MM X 127MM FEMORAL STEM
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
EI NA
Manufacturer Contact
joann lavatelli
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12363356
MDR Text Key268039549
Report Number0002249697-2021-01450
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040749
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial
Report Date 08/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6485-3-011
Device Catalogue Number64853011
Device Lot Number199509A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2018
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: 08/24/2021 Patient Sequence Number: 1
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