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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN C-TAPER LFIT FEMORAL HEAD HIP IMPLANT

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN C-TAPER LFIT FEMORAL HEAD HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Corroded (1131)
Patient Problems Inflammation (1932); Necrosis (1971); Discomfort (2330); Injury (2348); Reaction (2414); Ambulation Difficulties (2544)
Event Date 10/29/2016
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. Device not returned.
 
Event Description
It was reported through the filing of a lawsuit that allegedly "just over one year after his tha, the patient began experiencing significant discomfort and stiffness in his left lateral hip". It is further alleged on "(b)(6) 2016 his serum cobalt level was 4. 9 ng/ml and serum chromium was 1. 1 ng/ ml; mars mri taken on (b)(6) 2016 showed effusion suspect for altr. Based upon these findings. He underwent partial revision surgery on (b)(6) 2016 at which the time the surgeon encountered severe tissue necrosis and black sludge corrosion at the trunnion interface".
 
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Brand NameUNKNOWN C-TAPER LFIT 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
brad curtis
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7970166
MDR Text Key123865950
Report Number0002249697-2018-03386
Device Sequence Number1
Product Code KWY
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 10/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_JR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
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: 10/16/2018 Patient Sequence Number: 1
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