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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT ANATOMIC COCR V40 FEMORAL HEAD HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT ANATOMIC COCR V40 FEMORAL HEAD 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  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 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 LFIT ANATOMIC COCR V40 FEMORAL HEAD
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 Key7483614
MDR Text Key107245201
Report Number0002249697-2018-01328
Device Sequence Number1
Product Code LZO
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 05/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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: 05/03/2018 Patient Sequence Number: 1
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