MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6020-2530

Device Problem Material Integrity Problem (2978)

Patient Problems Injury (2348); Reaction (2414)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

An event regarding altr involving an accolade stem was reported.The event was not confirmed.Visual inspection was performed.The parts were examined with the aid of a stereo microscope at magnifications up to 50x.Biological fixation was observed on the stem.The stem was assumed to be a right hip implant.Discoloration was observed at the base of the trunnion.No material or manufacturing defects were observed on the surfaces examined.A review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, histopathology reports, progress notes and serial x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

Event Description

On (b)(6) 2009, the patient underwent the surgery with adept/ accolade tmzf.The complaint occurred to the patient's hip.When the surgeon did the diagnostic imaging, he found out that the implant (cup) is loose.And the symptom allergic to metal was seen by the around of the tissue.Therefore the patient underwent the revision surgery on (b)(6) 2016.

• Brand Name: ACCOLADE 132 SIZE 2.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: sarah smelko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6309679
• MDR Text Key: 66760214
• Report Number: 0002249697-2017-00494
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K121308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2017

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 Expiration Date: 07/31/2014
• Device Catalogue Number: 6020-2530
• Device Lot Number: 30497505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2009
• 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: 78 YR
• Patient Weight: 63