• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER ORTHOPAEDICS-MAHWAH SIZE 4 ACCOLADE II 127 DEG HIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES Back to Search Results
Catalog Number 6721-0435
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Pain (1994); Injury (2348)
Event Date 11/15/2014
Event Type  Injury  
Manufacturer Narrative

Should additional information become available, it will be submitted in a follow-up report upon completion of the investigation. Devices remain implanted.

 
Event Description

Occasional thigh pain following total hip replacement on (b)(6) 2013- product accolade ii. Patient reported thigh pain during study visit.

 
Manufacturer Narrative

An event regarding malposition involving an accolade stem was reported. Conclusion: based on the provided information, the product reported in this investigation did not contribute to the event. A review of the provided information by a clinical consultant concluded that: stem malposition in varus has caused direct contact of stem tip with lateral femoral cortex causing a local overload condition with secondary bone reactions of cortical hypertrophy and pedestal formation while further supported by the proximal calcar bone atrophy. These are all signs that are consistent with distal stem loading which represents a recognized cause for thigh pain. There is no allegation of failure against the trident shell. No further investigation is required at this time. If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

 
Event Description

Occasional thigh pain following total hip replacement on (b)(6) 2013- product accolade ii. Patient reported thigh pain during study visit.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSIZE 4 ACCOLADE II 127 DEG
Type of DeviceHIP JOINT METAL/POLYMER/METAL SEMI-CONSTRAINED POROUS-COATED UNCEMENTED PROSTHES
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
beverly lima
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key5084558
MDR Text Key26064289
Report Number0002249697-2015-03074
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK143085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/17/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2018
Device Catalogue Number6721-0435
Device LOT Number44131401
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/27/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/17/2015 Patient Sequence Number: 1
-
-