MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER STEM 25 OF 230; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 01/17/2019

Event Type  Injury  

Manufacturer Narrative

The information in this event 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.

Event Description

A review of the article "more reoperations for periprosthetic fracture after cemented ha with polished taper-slip stems: a study from the norwegian hip fracture register 2005 to 2016" reveals that 461 patients with exeter stems were revised.230 of those revisions occurred due to infection.

• Brand Name: EXETER STEM 25 OF 230
• 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: evelyn ryan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8306786
• MDR Text Key: 135056505
• Report Number: 0002249697-2019-00493
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/05/2019

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_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/05/2019
• 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