MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE PLUS TMZF HIP STEM #3; HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS.

Catalog Number 6021-0335

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); Injury (2348)

Event Date 12/12/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

Accolade tmzf bipolar hip was removed and the fracture was repaired w/plate and cables and screws.Restoration modular sleeve was implanted w/ uhr bipolar head.

Manufacturer Narrative

An event regarding periprosthetic fracture involving an accolade stem was reported.The event was confirmed.Method & results: device evaluation and results: the device was not returned for evaluation, however an image was provided.A review of the image by a clinical consultant noted: both stem and taper have normal appearance without signs for corrosion or other pathology.Some adherent bone indicates the stem was fixed to the bone prior to the fracture medical records received and evaluation: a review by a clinical consultant concluded: a patient fall at high age of (b)(6)-years quite likely caused a periprosthetic fracture around an accolade stem requiring fracture repair with stem revision.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: a review of the complaint history database shows that there have been no similar reported events for the reported lot.Conclusions: a review by a clinical consultant concluded: a patient fall at high age of (b)(6)-years quite likely caused a periprosthetic fracture around an accolade stem requiring fracture repair with stem revision.Further information such as return of device and clinical information are needed to complete the investigation.No further investigation is possible at the device was not returned and insufficient information was received.If additional information and/or device become available, this investigation will be reopened.

Event Description

Accolade tmzf bipolar hip was removed and the fracture was repaired w/plate and cables and screws.Restoration modular sleeve was implanted w/ uhr bipolar head.

• Brand Name: ACCOLADE PLUS TMZF HIP STEM #3
• Type of Device: HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS.
• 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: 5328806
• MDR Text Key: 34418840
• Report Number: 0002249697-2015-04491
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 6021-0335
• Device Lot Number: 47476201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 45