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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP STD R 65MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP STD R 65MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Model Number 6495-2-040
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Scar Tissue (2060)
Event Date 11/30/2020
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. The following devices were also listed in this report: cat# 64853115; mrs fem stem w/0 body 15x127mm; lot# 211205a. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Not returned to the manufacturer.
 
Event Description
It was reported that the patient's right knee was revised due to stiffness. All implants except the mrh tibial baseplate and stem extender were revised; however there are no allegations against the implants and stiffness was attributed only to scar tissue. Rep provided an explant picture and primary and revision usage sheets. The rep confirmed that no further information would be released by the hospital or surgeon.
 
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Brand NameGMRS DIST FEM COMP STD R 65MM
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 Key11035152
MDR Text Key222285677
Report Number0002249697-2020-02692
Device Sequence Number1
Product Code KRO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K023087
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 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number6495-2-040
Device Catalogue Number64952040
Device Lot NumberH9S4T
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 Received11/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2020
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: 12/18/2020 Patient Sequence Number: 1
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