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

Catalog Number 6021-0230

Device Problem Disassembly (1168)

Patient Problem No Code Available (3191)

Event Date 09/17/2014

Event Type  Injury  

Event Description

Revision total hip accolade tmzf.Head disassociated from the stem in patient.Surgeon pulled stryker components out and replaced with another vendor.

Manufacturer Narrative

It was noted that the device is not available for evaluation due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem was reported.The event was confirmed.Medical records received and evaluation: a review of the provided information by a clinical consultant confirmed the event but could not determine a root cause.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: 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 received.Further information such as device return, x-rays, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

Revision total hip accolade tmzf.Head disassociated from the stem in patient.Surgeon pulled stryker components out and replaced with another vendor.

• Brand Name: ACCOLADE PLUS 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: 4164170
• MDR Text Key: 4871999
• Report Number: 0002249697-2014-03837
• 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: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 6021-0230
• Device Lot Number: 19548502
• Other Device ID Number: STERILE LOT 0608P1RZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2006
• 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): Required Intervention