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

Catalog Number UNK_JR

Device Problems Degraded (1153); Material Deformation (2976)

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

Event Date 01/20/2015

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 is alleged through the filing of a lawsuit that the patient underwent a left total hip arthroplasty on (b)(6) 2006 where she was implanted with a stryker hip system.It is further alleged that more than one year after implantation, the plaintiff began to experience discomfort in her left hip.Further diagnosis workup revealed the presence of metallosis and trunnionosis, along with soft tissue inflammation.Based on this finding, the patients left hip was then revised on (b)(6) 2015.

• Brand Name: UNKNOWN ACCOLADE II TMZF PLUS 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7168199
• MDR Text Key: 96500707
• Report Number: 0002249697-2018-00062
• Device Sequence Number: 1
• Product Code: LZO
• 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: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention