MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT

Catalog Number 625-0T-28D

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Date 04/22/2015

Event Type  Injury  

Event Description

It was reported that patient had right total hip revised due to failed liner from impingement acetabular insert.The patient presented with pain and was revised.It was noted that a crack in the ceramic liner was observed.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding wear involving a trident liner and an unknown accolade stem was reported.The event was confirmed.Method & results: the device was not returned, however images were provided.The insert has an indented wear area on the metallic rim extending into the alumina insert where a metallic transfer is noted on the lip at the site of the metallic wear.A section of the ceramic part of the insert had broken away from the insert.A dimensional and functional inspection was not performed as the device was not returned.A review of the medical information by a clinical consultant indicated that: after seven years in situ, repeated impingement by the neck of the femoral component on the metallic rim of the insert resulted in penetrant wear.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.Device history review and complaint history review could not be performed as the lot id is unknown.Conclusions: a review by a clinical consultant concluded that after seven years in situ, repeated impingement by the neck of the femoral component on the metallic rim of the insert resulted in penetrant wear.There is no evidence that factors of faulty component design, manufacturing or materials were responsible for this clinical situation.The exact root cause of the event could not be determined as insufficient information was provided.If additional information such as revision operative reports, x-rays and/or device become available, this investigation will be reopened.

Event Description

It was reported that patient had right total hip revised due to failed liner from impingement acetabular insert.The patient presented with pain and was revised.It was noted that a crack in the ceramic liner was observed.

• Brand Name: TRIDENT ALUMINA INSERT
• 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4781548
• MDR Text Key: 17204136
• Report Number: 0002249697-2015-01616
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000013
• 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: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2015
• 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): Life Threatening; Other; Required Intervention
• Patient Age: 62 YR