MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32E

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 10/02/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there were no similar events for the reported lot.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Additional devices listed in this event: catalog: 6565-0-032, description: alumina v40-femoral head 32mm, -4mm, lot: 0705xira; catalog: 2030-6525-1, description: 6.5 cancellous bone screw 25mm, lot: 5eampd; catalog: 2030-6535-1, description: 6.5 cancellous bone screw 35mm, lot: 8a2med; catalog: 2060-0000-1, description: acetabular dome hole plug dome plug, lot: 308mpd; catalog: 502-01-54e, description: trident hemispherical cluster 54mm trident shell, lot: 23147801; catalog: 6020-0537, description: accolade tmzf hip stem #5 accolade stem, lot: 22826501.At this time, it cannot be determined which, if any of the reported devices may have caused or contributed to the patient's experience.Not returned to the manufacturer.

Event Description

Explantation of trident 0 degree alumina insert (alpha code e) and v40 alumina 32mm -4mm femoral head secondary to infection and subsequent mdm liner, x3 insert, 28mm ceramic head, and v40 universal adapter sleeve.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8021502
• MDR Text Key: 125587255
• Report Number: 0002249697-2018-03552
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2012
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 22909902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2007
• 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: 74 YR