MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 3.0 ACCOLADE I 127° STEM; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Injury (2348)

Event Date 05/03/2018

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 returned to the manufacturer.

Event Description

This pi is for patient 22 of 30, a 36 +5 head and accolade i size 3.0 127° stem were revised for "bottoming out" (defined as wear at the base of the female head taper indicating contact with the tip of the male stem taper), trunnion wear (gross trunnion failure), and disassociation.The journal of arthroplasty article "head taper corrosion causing head bottoming out and consecutive gross stem taper failure in total hip arthroplasty" indicates patient's hip was revised due to wear of the head, trunnion wear (gross trunnion failure), and disassociation.This article was included in the quarterly journal review conducted at the end of the q4 2018.Of the 30 events documented in this article, the complaint history review identified 28 unique events that were not previously reported.

• Brand Name: SIZE 3.0 ACCOLADE I 127° STEM
• 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: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8310976
• MDR Text Key: 135184384
• Report Number: 0002249697-2019-00587
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• 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
• Date Manufacturer Received: 01/10/2019
• 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