MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 6021-2530

Device Problems Metal Shedding Debris (1804); Device Dislodged or Dislocated (2923); Material Deformation (2976); Scratched Material (3020)

Patient Problems Injury (2348); Joint Dislocation (2374)

Event Date 05/06/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient's hip was dislocated, and the head detached from the stem neck.Upon opening, the doctor discovered that the femoral component was damaged and the stem was then removed and replaced along with the femoral head and polyethylene liner.Images were received which show "pencilling effect" on stem.

Manufacturer Narrative

An event regarding disassociation involving an accolade stem that was mated with a metal head was reported.The event was confirmed through visual inspection of the provided photographs.The reported device was not returned however photographs were provided for review.The photographs shows a recently explanted head and stem.Scratches and debris on the head is consistent with in vivo use and a recently explanted device.The stem has blood and bony ingrowth visible on it.The neck of the stem appears worn with a pencilling effect.Only a partial view of the liner can be seen from one of the photographs which appears unremarkable.Medical records received and evaluation: not performed as no medical records were received for evaluation.Indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.The exact cause of the reported event could not be confirmed based on the information provided.Further information such as such product return, pre and post operative x-rays, operative reports, as well as patient history and follow up notes are required to complete the investigation for determining a root cause.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Patient's hip was dislocated, and the head detached from the stem neck.Upon opening, the doctor discovered that the femoral component was damaged and the stem was then removed and replaced along with the femoral head and polyethylene liner.Images were received which show "pencilling effect" on stem.

• Brand Name: ACCOLADE (127 DEG) SIZE 2.5 ACCOLADE (127 DEG) SIZE 2.5
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7550435
• MDR Text Key: 109453694
• Report Number: 0002249697-2018-01627
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• 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: 07/03/2018

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: 03/31/2011
• Device Catalogue Number: 6021-2530
• Device Lot Number: 17564602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2018
• Initial Date FDA Received: 05/29/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2006
• 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: 79 YR