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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 13MMX203MM FEMORAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRS 13MMX203MM FEMORAL STEM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64853313
Device Problem Osseointegration Problem (3003)
Patient Problems Injury (2348); Inadequate Osseointegration (2646)
Event Date 08/19/2019
Event Type  Injury  
Manufacturer Narrative
A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies. There have been no other events for the lot referenced. If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
 
Event Description
It was reported that the patient's right knee was revised due to a loose femoral stem. The entire construct except for the tibial baseplate and tibial stem were revised. Spoke to rep. Rep confirmed the only allegation was for the femoral stem. Rep provided primary and revision usage and explant pictures, and confirmed that no further information.
 
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Brand NameMRS 13MMX203MM 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
Manufacturer Contact
sharon rivas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key9070566
MDR Text Key161585020
Report Number0002249697-2019-03195
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 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number64853313
Device Lot Number114449A
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 Received08/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2012
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: 09/16/2019 Patient Sequence Number: 1
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