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

Catalog Number 625-0T-28D

Device Problems Material Discolored (1170); Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Date 12/30/2014

Event Type  Injury  

Event Description

It was reported that doctor had a patient come into his office with a painful hip and a notable clunk.Dr.Made the determination to revise the previously implanted components after examination.The patient had surgery to replace these components on (b)(6) 2014.The patient was revised through an anterior lateral incision.Before removing the head and liner dr.Excised garish colored tissue in and around the hip joint.A stryker alumina head and liner were removed from the patient.The head had black and gray markings on the surface.The liner had similar black and gray markings.The liner also appeared to be chipped on the rim where the alumina ceramic and metal met.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding fracture involving a trident liner was reported.The event was confirmed.Method and results: device evaluation and results: material loss and chipping of the alumina insert rim was observed in addition to damage and deformation to a section of the sleeve rim.It was not possible to determine the fracture origin of the insert due to the condition of the fracture surface.The articulating surface of the insert contained metal transfer markings and wear indications throughout multiple areas of the surface.The material damage morphology and their locations observed on the insert and the articulating surface of the head were consistent with damage due to edge-loading.The material damage observed on the sleeve rim is likely due to contact with the stem neck.The material analysis report concluded that the material damage observed on the sleeve rim is likely due to contact with the stem neck.No material or manufacturing defects were observed on the device features examined.Medical records received and evaluation: records were not provided for review.Device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies complaint history review: a review of the complaint history database shows that there have been no similar reported events for the subject lot code.Conclusions: the exact cause of the fracture could not be determined based on the information available.The material analysis report indicated that it was not possible to determine the fracture origin of the insert due to the condition of the fracture surface.

Event Description

It was reported that doctor had a patient come into his office with a painful hip and a notable clunk.Dr.Made the determination to revise the previously implanted components after examination.The patient had surgery to replace these components on (b)(6) 2014.The patient was revised through an anterior lateral incision.Before removing the head and liner dr.Excised garish colored tissue in and around the hip joint.A stryker alumina head and liner were removed from the patient.The head had black and gray markings on the surface.The liner had similar black and gray markings.The liner also appeared to be chipped on the rim where the alumina ceramic and metal met.

• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4442852
• MDR Text Key: 5314179
• Report Number: 0002249697-2015-00167
• 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: 12/30/2014

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: 03/31/2008
• Device Catalogue Number: 625-0T-28D
• Device Lot Number: U5171002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 01/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2003
• 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): Required Intervention
• Patient Age: 59 YR