MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH THOMPSON ENDOPROSTHESIS 4 OF 6; HIP IMPLANT

Catalog Number UNK_JR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

This article was included in the quarterly journal review conducted at the end of the q4 2018.If additional information is received, it will be provided in a follow up report.Not returned.

Event Description

It was reported in "management and outcome of the dislocated hip hemiarthroplasty": "of 3326 consecutive patients treated with hemiarthroplasty for fractured neck of femur, 46.Sustained dislocations".A table is provided identifying 6 of the 46 patients with the thompson endoprosthesis.This article was included in the quarterly journal review conducted at the end of the q4 2018.

• Brand Name: THOMPSON ENDOPROSTHESIS 4 OF 6
• Type of Device: 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8289145
• MDR Text Key: 134491650
• Report Number: 0002249697-2019-00371
• Device Sequence Number: 1
• Product Code: JDD
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2019

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: 01/15/2019
• Initial Date FDA Received: 01/30/2019
• 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