MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; IMPLANT

Catalog Number 6021-0435

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/23/2014

Event Type  Injury  

Event Description

It was reported that the patient claims that never pain free after primary surgery.The surgeon saw patient and took x-rays.It was decided patient needed hip revised and relocated.During revision dr.Noted that the trunnion had remarkable wear so much that the femoral head would not securely seat on the taper.He then decided to cement a femoral head onto the existing stem and change the acetabular liner.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding pain and wear involving an accolade stem was reported.The event was not confirmed.Device evaluation not performed as the reported device was not returned for evaluation.A medical review was not performed because insufficient information was provided.Device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review indicated there have been no other events for the reported lot.The exact cause of the event could not be determined because insufficient information was provided.

Event Description

It was reported that the patient claims that never pain free after primary surgery.The surgeon saw patient and took x-rays.It was decided patient needed hip revised and relocated.During revision dr.Noted that the trunnion had remarkable wear so much that the femoral head would not securely seat on the taper.He then decided to cement a femoral head onto the existing stem and change the acetabular liner.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• Type of Device: 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3824971
• MDR Text Key: 4451749
• Report Number: 0002249697-2014-01874
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2010
• Device Catalogue Number: 6021-0435
• Device Lot Number: 11957106
• Other Device ID Number: STER. LOT 0502GIRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2005
• 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
• Patient Age: 81 YR