MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-10-36E

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Pain (1994); Injury (2348)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.The following devices were also listed in this report: trident psl ha solid back 50mm; cat# 540-11-50e; lot# 40361801; delta v-40 ceramic head 36/-5; cat# 6570-0-036; lot# 34937702; abgii no6 cementless left v40; cat# 4845-0206; lot# g2996280d; it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Device not returned to the manufacturer.

Event Description

The patient reported that she underwent a hip prosthesis surgery.In 2013 she began to have pain in the prosthetic site increased in 2017 along with pain and intermittent daily fever.In 2018 she was affected by prosthesis infection and was explanted.

• Brand Name: TRIDENT 10° X3 INSERT 36MM ID
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8202390
• MDR Text Key: 131592754
• Report Number: 0002249697-2018-04148
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327039917
• UDI-Public: 07613327039917
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2018

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: 05/31/2017
• Device Catalogue Number: 623-10-36E
• Device Lot Number: 40410501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2012
• 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