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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT 40 HEAD; HIP IMPLANT
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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT 40 HEAD; HIP IMPLANT Back to Search Results
Catalog Number UNK_JR
Device Problem Insufficient Information (3190)
Patient Problems Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 03/10/2017
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.Not returned.
 
Event Description
Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total hip arthroplasty on (b)(6) 2011 that failed and required revision on (b)(6) 2017 due to elevated levels of cobalt and chromium revealed in blood work.
 
Event Description
Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a left total hip arthroplasty on (b)(6) 2011 that failed and required revision on (b)(6) 2017 due to elevated levels of cobalt and chromium revealed in blood work.
 
Manufacturer Narrative
This pi has been identified as a duplicate entry.All further reporting will be captured under the original report, mfr# 0002249697-2017-01144.
 
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Brand Name
UNKNOWN LFIT 40 HEAD
Type of Device
HIP IMPLANT
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
MDR Report Key8268744
MDR Text Key133832280
Report Number0002249697-2019-00260
Device Sequence Number1
Product Code JDG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_JR
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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