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

Catalog Number 625-0T-36G

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/13/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a left total hip revision due to ceramic liner breakage.The head and liner were exchanged.

Manufacturer Narrative

An event regarding crack/fracture of a trident liner was reported.The event was confirmed by visual inspection of the returned device.The material analysis concluded that metal transfer markings were observed on the articulating surface of the ceramic head, likely from interacting with the trident alumina insert.A metal transfer ring was present indicating correct seating on the stem trunnion.No material or manufacturing defects were observed on the surfaces examined.A review of the provided information by a clinical consultant indicated that cup malposition in high anteversion contributed to impingement between stem/neck and cup rim causing point contact with extreme overload in the ceramic bearing resulting in a ceramic liner fracture.These effects were aggravated by the morbid obesity of patient.Device history review indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.The complaint history review indicated there have been no other similar events for the reported lot.

Event Description

It was reported that the patient underwent a left total hip revision due to ceramic liner breakage.The head and liner were exchanged.

• 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: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5069679
• MDR Text Key: 25480281
• Report Number: 0002249697-2015-02963
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/13/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2008
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: U7287702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2003
• 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; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 167