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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRH AXLE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

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STRYKER ORTHOPAEDICS-MAHWAH MRH AXLE PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 64812120
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative
It was noted that the device is not available for evaluation. Should additional information become available, it will be provided in a supplemental report upon completion of the investigation. The following devices were also listed in this report: mrhk bumper insert - neutral; cat#64812130; lot#ldj174. Mrhk femoral bushing; cat#64812110; lot#unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
 
Event Description
It was reported that the patient's left total distal femur was revised after patient complaint of pain. Intra-operatively, the axle was found to be broken. No other cause or contributor to pain was reported.
 
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Brand NameMRH AXLE
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
joanne mahony
ida industrial estate
carrigtwohill NA
214532800
MDR Report Key8204649
MDR Text Key131701733
Report Number0002249697-2018-04189
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number64812120
Device Lot NumberCTD2513
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2013
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: 12/28/2018 Patient Sequence Number: 1
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