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

Catalog Number 6020-0335

Device Problems Corroded (1131); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Pain (1994); Test Result (2695)

Event Date 02/12/2014

Event Type  Injury  

Event Description

It was reported that the patient complained of pain and had elevated chromium levels so the accolade right hip was revised.Corrosion was noted on the trunnion intraoperatively.

Manufacturer Narrative

Catalog, lot number, steri-lot, expiration, 510k #, and manufacturing date updated.An event regarding corrosion and elevated metal levels involving an accolade tmzf hip stem #3 was reported.The event was not confirmed.A photograph of the device noted dark material on the trunnion.A review of the provided medical records by a clinical consultant indicated, ¿it is not likely that the patient¿s vague symptoms bilaterally are the result of factors related to prosthetic components¿ design, manufacturing, or materials.¿ a device history review concluded all devices accepted into finished goods conformed to specification.A complaint history review confirmed no other similar events for the reported lot.The exact cause of the event could not be determined because further information is needed to complete the investigation for determining the root cause.No further investigation for this event is possible at this time.

Event Description

It was reported that the patient complained of pain and had elevated chromium levels so the accolade right hip was revised.Corrosion was noted on the trunion intraoperatively.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported to be an unknown accolade stem.Additional information has been requested and if received, will be provided in the supplemental report.Patient retained device.

• Brand Name: ACCOLADE 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3668504
• MDR Text Key: 4950447
• Report Number: 0002249697-2014-00708
• 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: 02/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2010
• Device Catalogue Number: 6020-0335
• Device Lot Number: 14714904
• Other Device ID Number: 0509AIRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2005
• 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: 64 YR
• Patient Weight: 79