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U.S. Department of Health and Human Services

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

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STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE TMZF FEMORAL STEM HIP IMPLANT Back to Search Results
Catalog Number UNK_SHC
Device Problem Corroded (1131)
Patient Problems Edema (1820); Inflammation (1932); Injury (2348); Reaction (2414)
Event Date 01/26/2017
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 "diagnostic workup revealed an increased serum cobalt level of 3. 9 ng/ml, and an mri demonstrated a large soft tissue mass. Based upon these findings, plaintiff's orthopedic surgeon's impression was altr resulting from corrosion at the junction between the accolade tmzf and the lfit v40 head, and he recommended revision surgery. Plaintiff underwent revision surgery on 1/13/2015 at which time the surgeon encountered chronic inflammatory changes, altr, trunnionosis and corrosion".
 
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Brand NameUNKNOWN ACCOLADE TMZF FEMORAL 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
sarah smelko
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key6356758
MDR Text Key68268693
Report Number0002249697-2017-00653
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 consumer,other
Reporter Occupation
Type of Report Initial
Report Date 02/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SHC
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 Received01/26/2017
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: 02/24/2017 Patient Sequence Number: 1
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