MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE TMZF HIP STEM #1; IMPLANT

Catalog Number 6020-0130

Device Problems Corroded (1131); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 04/09/2014

Event Type  Injury  

Event Description

It was reported that the surgeon has expressed concerns with accolade tmzf stem in regards to the trunion.He has experienced the head impinging on the neck of the stem causing trunninosis.The case involved a very large head size on the stem (40mm+) which could lead to the head impinging on the stem.

Manufacturer Narrative

It was noted that the device is currently implanted.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 corrosion and possible trunnionosis involving an accolade stem was reported.The event was not confirmed.Conclusions: the exact cause of the event could not be determined as further information such as pre- and post-operative x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

It was reported that the surgeon has expressed concerns with accolade tmzf stem in regards to the trunion.He has experienced the head impinging on the neck of the stem causing trunninosis.The case involved a very large head size on the stem (40mm+) which could lead to the head impinging on the stem.

• Brand Name: ACCOLADE TMZF HIP STEM #1
• 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: 3781243
• MDR Text Key: 4358394
• Report Number: 0002249697-2014-01628
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6020-0130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 72 YR