MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #2; IMPLANT

Catalog Number 6020-0230

Device Problem Corroded (1131)

Patient Problems Pain (1994); Toxicity (2333)

Event Date 11/24/2014

Event Type  Injury  

Event Description

The patient had metal corrosion and high chromium levels with associated right hip pain.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.Device not available.

Manufacturer Narrative

The patient is (b)(6) in height.An event reporting altr and high chromium levels (altr) involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as the reported device was not returned for evaluation.-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.-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.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

The patient had metal corrosion and high chromium levels with associated right hip pain.

• Brand Name: ACCOLADE TMZF HIP STEM #2
• 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: 4352529
• MDR Text Key: 5139089
• Report Number: 0002249697-2014-04804
• 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: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 6020-0230
• Device Lot Number: 34945902
• Other Device ID Number: STER. LOT 1101DCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2011
• 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: 57 YR