MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN LFIT ANATOMIC COCR V40 FEMORAL HEAD; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 12/23/2015

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

Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a right total hip arthroplasty on (b)(6) 2010 that failed and required revision on (b)(6) 2015.

Manufacturer Narrative

This pi has been identified as a duplicate.If any additional information is received, it will be reported under mfr# 0002249697-2016-00150.

Event Description

Its reported by the attorney, through the filing of a lawsuit, that the plaintiff underwent a right total hip arthroplasty on (b)(6) 2010 that failed and required revision on (b)(6) 2015.

• Brand Name: UNKNOWN LFIT ANATOMIC COCR V40 FEMORAL HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8248697
• MDR Text Key: 133109762
• Report Number: 0002249697-2019-00181
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 02/07/2019
• Supplement Dates FDA Received: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention