MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_RECONSTRUCTIVE_PRODUCT; IMPLANT

Catalog Number UNK_REC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erosion (1750); Toxicity (2333)

Event Date 10/11/2012

Event Type  Injury  

Event Description

It was reported through the filing of a lawsuit that allegedly diagnostic workup revealed the presence of markedly increased levels of metal ions in the patient's blood and potential existence of a fluid collection about the hip prosthesis.Based upon this finding and in light of patient's worsening symptoms, she was taken back for revision surgery to her right hip on (b)(6) 2014.It is further alleged that during the revision surgery, "there was significant evidence of heavy metal toxicity including the presence of cloudy, turbid fluid, erosion around the head neck taper junction between the accolade stem and lfit v40 chromium cobalt femoral head.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown lfit anatomic v40 femoral head.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.

• Brand Name: UNKNOWN_RECONSTRUCTIVE_PRODUCT
• 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: 4200411
• MDR Text Key: 4961071
• Report Number: 0002249697-2014-03983
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• 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
• Date Manufacturer Received: 09/29/2014
• 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