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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HIP HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problems Corroded (1131); Material Discolored (1170)
Patient Problems Death (1802); Edema (1820); Unspecified Infection (1930); Necrosis (1971); Pain (1994); Injury (2348)
Event Date 01/08/2015
Event Type  Death  
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 began to experience pain and was evaluated by her physicians. She underwent revision surgery on (b)(6) 2015 and during this procedure, the surgeon "found significant necrosis and fluid within the hip and gluteus minimus. As he performed the procedure, he encountered additional necrosis within the abductors and soft tissue, and there was corrosion and black staining under the ball and surrounding taper. " it is further alleged that on (b)(6) 2015 as a direct and proximate result of a post-operative infection that developed after revision surgery, the patient died.
 
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Brand NameUNKNOWN HIP
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
timothy rice
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7480633
MDR Text Key107148344
Report Number0002249697-2018-01321
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
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 Received04/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/02/2018 Patient Sequence Number: 1
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