MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 4.5 ACCOLADE TMZF PLUS FEMORAL HIP STEM HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Material Deformation (2976)

Patient Problems Edema (1820); Inflammation (1932); Discomfort (2330); Injury (2348); Reaction (2414)

Event Date 06/26/2014

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 available.

Event Description

It was reported through the filing of a lawsuit that the plaintiff underwent a total hip arthroplasty on (b)(6) 2007. It is further alleged that several years after implantation, the plaintiff began experiencing discomfort in the area of the device. The patient's hip was then revised on (b)(6) 2014 and during this surgery, "it was discovered that there was metallosis and trunnionosis in plaintiff's hip along with fluid under pressure".

• Brand Name: UNKNOWN 4.5 ACCOLADE TMZF PLUS FEMORAL HIP STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6977953
• MDR Text Key: 90282312
• Report Number: 0002249697-2017-03108
• 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: other

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• 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: 09/28/2017
• 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: 10/25/2017 Patient Sequence Number: 1