MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; IMPLANT

Catalog Number 6021-0335

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tinnitus (2103); Toxicity (2333); Palpitations (2467)

Event Date 06/19/2007

Event Type  Injury  

Event Description

It was reported patient had a left total hip implanted and has pain in groin and leg.Patient also reported she has ringing in her ear, heart palpitation and metallosis.Patient is schedule for revision surgery.

Manufacturer Narrative

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

Manufacturer Narrative

An event reporting pain, metallosis (altr) and a recall inquiry involving an accolade stem was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as the reported device was not returned for evaluation.The patient retained the device.Medical records received and evaluation: a medical review was not performed because insufficient information was provided.Device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.The device was not part of any recall.Complaint history review: review indicated there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.The device was not part of any recall.Additional information, including operative reports, progress notes, pathology reports x-rays and return of the device are needed to fully investigate the event.

Event Description

As per additional information received, the patient has since been revised.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4343445
• MDR Text Key: 5180141
• Report Number: 0002249697-2014-04776
• 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,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2012
• Device Catalogue Number: 6021-0335
• Device Lot Number: 22065703
• Other Device ID Number: STERILE LOT CAC4V1R2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2007
• 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): Other
• Patient Age: 41 YR