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

Catalog Number UNK_REC

Device Problem Material Erosion (1214)

Patient Problems Necrosis (1971); Pain (1994); Discomfort (2330); Toxicity (2333)

Event Date 01/24/2014

Event Type  Injury  

Manufacturer Narrative

The catalog number and lot code were not provided.The information in this report was provided by stryker orthopaedics legal affairs.No additional information is available at this time due to ongoing litigation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Legal case.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient underwent a total hip arthroplasty on (b)(6) 2005 in which he was implanted with a stryker hip.After implantation of the device, the patient began experiencing pain and discomfort in the area of the device.Further diagnostic workup revealed the presence of markedly increased levels of metal ions in the patients blood.It is further alleged that the patient was revised on (b)(6) 2013 and again on (b)(6) 2014 and during surgery discovered significant evidence of heavy metal toxicity including me presence of cloudy, turbid fluid, erosion around the neck taper, and significant soft tissue necrosis.

• Brand Name: UNKNOWN LFIT ANATOMIC V40 FEMORAL HEAD
• Type of Device: 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5197252
• MDR Text Key: 30236101
• Report Number: 0002249697-2015-03616
• Device Sequence Number: 1
• Product Code: JDG
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2015

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_REC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2015
• Initial Date FDA Received: 11/03/2015
• 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