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

Catalog Number UNK_REC

Device Problem Insufficient Information (3190)

Patient Problems Discomfort (2330); Toxicity (2333)

Event Date 08/13/2009

Event Type  Injury  

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.

Event Description

It was reported by the patient's attorney through the filing of a lawsuit that allegedly the patient was implanted with an accolade hip stem and v40 femoral head on (b)(6) 2009.It is further alleged that after implantation of the device, the patient began experiencing discomfort in the area of the device.Diagnostic workup revealed the presence of markedly increased levels of metal ions in the patients blood and or urine.The patient was then revised on an unknown date.

• 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: 5050173
• MDR Text Key: 24892537
• Report Number: 0002249697-2015-02910
• 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
• Report Date: 08/10/2015

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: Not provided
• Initial Date FDA Received: 09/02/2015
• 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