MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; IMPLANT

Catalog Number 6020-3535

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/29/2014

Event Type  Injury  

Event Description

Patient had peri prosthetic fracture on a left hip.Accolade tmzf 3.5 and biolox head were removed and replaced.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available, the evaluation summary will be submitted in a supplemental report.Not returned to manufacturer.

Manufacturer Narrative

An event regarding periprosthetic fracture involving an accolade stem was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed, no device returned as per hospital policy.-medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.-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 return of the device, pre- and post-operative x-rays, operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

Patient had peri prosthetic fracture on a left hip.Accolade tmzf 3.5 and biolox head were removed and replaced.

• Brand Name: ACCOLADE 132 SIZE 3.5
• 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: 4354040
• MDR Text Key: 5199295
• Report Number: 0002249697-2014-04861
• 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: 11/29/2014

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: 06/30/2019
• Device Catalogue Number: 6020-3535
• Device Lot Number: 47878703
• Other Device ID Number: STERILE LO1406RCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2011
• 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): Required Intervention
• Patient Age: 81 YR