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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH GMRS DIST FEM COMP SML R 65MM PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64952020
Device Problem Insufficient Information (3190)
Patient Problems Necrosis Of Flap Tissue (1972); Injury (2348)
Event Date 01/05/2018
Event Type  Injury  
Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no relevant reported discrepancies. There have been no other events for the lot referenced. It was noted that the device is not available for evaluation. If additional information is received, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: mrh xs/s/m long xover; cat#64812103; lot# 106953b, mrhk bumper insert ¿ neutral; cat#64812130; lot# lga733, gmrs small femoral bushing; cat#64952105; lot#lfy032, gmrs small femoral bushing; cat#64952105; lot#lfy029, gmrs small axle; cat#64952115; lot# ctd19363, gmrs extension piece 40mm; cat#64956040; lot#cxs7l. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Not available.
 
Event Description
It was reported that patient's right knee was revised due to possible infection (pathology confirmed the absence of infection). Intra-operatively, excessive fluid and possibly necrotic tissue were observed.
 
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Brand NameGMRS DIST FEM COMP SML 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
Manufacturer Contact
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7238391
MDR Text Key98914255
Report Number0002249697-2018-00313
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 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number64952020
Device Lot NumberB923D
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 Received01/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2017
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: 02/02/2018 Patient Sequence Number: 1
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