MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN HIP SYSTEM; UNKNOWN HIP IMPLANT

Catalog Number UNK_JR

Device Problem Insufficient Information (3190)

Patient Problems Cyst(s) (1800); Edema (1820); Inflammation (1932); Injury (2348); Reaction (2414)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Not available.

Event Description

Tha due to hip osteoarthritis was done right hip at (b)(6) 2010 and left hip at (b)(64) 2011 with centpiller tmzf stem, trident cup, v40 head and x3 liner.At (b)(6) 2017, the patient noticed a tumor of both hip joint at the setting position and visit a hospital.Loosening was not confirmed at x-p and a tumor of both hip joint was confirmed at mri.Serum co ion concentration was as high as 23.5ng/ml, and the doctor suspected a pseudotumor by armd.This pi is in relation to the right hip.

• Brand Name: UNKNOWN HIP SYSTEM
• Type of Device: UNKNOWN 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: diana avila ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7711212
• MDR Text Key: 114737453
• Report Number: 0002249697-2018-02268
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/23/2018
• 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