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

Catalog Number 6020-0335

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2014

Event Type  malfunction  

Event Description

It was reported during initial surgery of right hip there was an issue with accolade tmzf stem.Doctor went to broach #3 stem.Implant and stem sat proud about 1cm.Doctor took out number 3 and insert 2 1/2 stem, this led to a delay in surgery.

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Manufacturer Narrative

An event regarding an accolade tmzf stem that sat proud was reported.The event was not confirmed.A review of the device history records indicates that all devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for this lot.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.

Event Description

It was reported during initial surgery of right hip there was an issue with accolade tmzf stem.Doctor went to broach #3 stem.Implant and stem sat proud about 1cm.Doctor took out number 3 and insert 2 1/2 stem, this led to a delay in surgery.

• 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: 3852175
• MDR Text Key: 4655753
• Report Number: 0002249697-2014-02132
• 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: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 6020-0335
• Device Lot Number: 45918103
• Other Device ID Number: STER. LOT 1901ICM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2014
• 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): Other
• Patient Age: 71 YR
• Patient Weight: 100