MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ACCOLADE STEM; HIP IMPLANT

Catalog Number UNK_JR

Device Problems Degraded (1153); Material Deformation (2976)

Patient Problems Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding wear (metallosis and trunnionosis) involving an unknown accolade stem was reported.The event was not confirmed.Method & results: product evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Product history review: not performed as the device was not properly identified.Complaint history review: not performed as the device was not properly identified.Conclusions: the event could not be confirmed nor the root cause determined as insufficient information was provided.The patient was revised due to trunnionosis and metallosis.However, the unknown accolade stem remained implanted.Further information such as device details, return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device become available, this investigation will be reopened.

Event Description

Removal of femoral head and liner.Patient complained of pain.The patient was revised due to trunnionosis and metallosis but the accolade stem was left implanted.

Event Description

Removal of femoral head and liner.Patient complained of pain.The patient was revised due to trunnionosis and metallosis but the accolade stem was left implanted.

Manufacturer Narrative

Corrected data: g1 - manufacturing site for devices.

• Brand Name: UNKNOWN ACCOLADE STEM
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7685273
• MDR Text Key: 113889273
• Report Number: 0002249697-2018-02163
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 91