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

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Naturally Worn (2988)

Patient Problems Discomfort (2330); Injury (2348); Osteolysis (2377); Inadequate Osseointegration (2646)

Event Date 05/17/2016

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 allegedly after implantation of the device the patient began experiencing discomfort and complications in her hip and due to elevated risk and instability in her right hip she underwent revision surgery on (b)(6) 2016.It is further alleged that during surgery, it was discovered there was significant evidence of trunnionosis around the proximal femur at the junction between the head and neck and the operative report also noted areas of osteolysis, bone loss, and loosening of the femoral component.It is alleged that once her surgeon removed the acetabulum, he noticed "a severe amount of bone loss and osteolysis in the space behind the patient's acetabular dome.".

• Brand Name: UNKNOWN LFIT ANATOMIC V40 FEMORAL HEAD
• 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: brian lauro ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6720097
• MDR Text Key: 80246371
• Report Number: 0002249697-2017-02198
• 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: 07/17/2017

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2017
• Initial Date FDA Received: 07/17/2017
• 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