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

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".

• Brand Name: UNKNOWN ACCOLADE TMZF FEMORAL STEM
• Type of Device: HIP 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 Key: 6356758
• MDR Text Key: 68268693
• Report Number: 0002249697-2017-00653
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/26/2017
• 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