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

Catalog Number UNK_SHC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); Toxicity (2333)

Event Date 11/12/2015

Event Type  Injury  

Manufacturer Narrative

The information in this report was provided by stryker orthopaedics legal affairs.No additional information is available at this time due to ongoing litigation.Based on the limited information provided, the event could not be confirmed and the cause could not be determined.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 an accolade tmzf hip stem and lfit anatomic v40 femoral head were implanted on (b)(6) 2012.It is further alleged that "after implantation the patient began experiencing discomfort in the area of the device.Additional diagnostic workup revealed the presence of markedly increased levels of metal ions in the patient's blood and/or urine.As a result, the patient was forced to have the device surgically removed.".

• Brand Name: UNKNOWN ACCOLADE TMZF HIP STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5263673
• MDR Text Key: 32598506
• Report Number: 0002249697-2015-04124
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

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_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/03/2015
• 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