MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN EXETER STEM 82 OF 123; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Unstable (1667)

Patient Problem 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.Not available.

Event Description

This pi is for the 123 revisions of patients with exeter stems due to instability.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.123 of those revisions occurred due to instability.

• Brand Name: UNKNOWN EXETER STEM 82 OF 123
• 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: juana hiciano ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8308880
• MDR Text Key: 135135413
• Report Number: 0002249697-2019-00542
• Device Sequence Number: 1
• Product Code: JDG
• 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
• 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
• 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