MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #4; IMPLANT

Catalog Number 6021-0435

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 04/03/2015

Event Type  Injury  

Event Description

It was reported the surgeon did a revision on a patient's.Right hip.The patient presented in the er with the femoral head disassociated from the neck.He removed the stem, head, and liner and replaced with a cone/ conical stem ceramic head and constrained liner.

Manufacturer Narrative

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

Manufacturer Narrative

Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Provided pictures confirm the reported event.The head dissociated from the stem.The stem trunnion was deformed.The root cause of the reported dissociation could not be determined due to the minimal information received.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If the devices or additional information become available, this investigation will be reopened.

Event Description

It was reported the surgeon did a revision on a patient's.Right hip.The patient presented in the er with the femoral head disassociated from the neck.He removed the stem, head, and liner and replaced with a cone/ conical stem ceramic head and constrained liner.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #4
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK (MDR); ida industrial estate; carrigtwohill 00000 ; EI 00000
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4730982
• MDR Text Key: 5739016
• Report Number: 0002249697-2015-01384
• 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,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 6021-0435
• Device Lot Number: 21382302
• Other Device ID Number: STER. LOT 0701RIRZ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2007
• 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: 81 YR
• Patient Weight: 88