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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HIP STEM HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HIP STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Material Deformation (2976)
Patient Problems Cyst(s) (1800); Edema (1820); Pain (1994); Discomfort (2330); Injury (2348)
Event Date 11/15/2017
Event Type  Injury  
Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department. No additional information is available at this time due to the ongoing litigation. Should additional information become available, the evaluation summary will be submitted in a supplemental report.
 
Event Description
It was reported through the filing of a lawsuit that allegedly the patient underwent a right tha on or about (b)(6) 2008 and after implantation he began to experience progressive pain and discomfort. It is further alleged that the patient's right hip had developed pseudo tumor secondary to trunnionosis and that this was the cause of his pain. He underwent revision surgery on his right hip.
 
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Brand NameUNKNOWN HIP STEM
Type of DeviceHIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
merin grace
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7110829
MDR Text Key94623449
Report Number0002249697-2017-03573
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/12/2017 Patient Sequence Number: 1
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