MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL WITH PUREFIX HA 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 542-11-54F

Device Problem Malposition of Device (2616)

Patient Problems Foreign Body Reaction (1868); Pain (1994)

Event Date 12/20/2021

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.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.

Event Description

As reported: "right side hip revision, all components explanted were stryker components.The patient was re-implanted with all new revision components, and the case sheet is attached.The original surgery was done in 2011, the patient recently was reporting pain in his right hip, x-rays showed eccentric wear on the polyethylene component, as well as the femoral head on the trunnion.The patient¿s cobalt chrome levels were elevated, so the surgeon decided to revise the hip component.Adverse local tissue reactions were minimal, however the femoral head did have corrosion and fretting was noted on the trunnion.A portion of the superior lip of the polyethylene liner was fractured off.The locking mechanism was intact on the polyethylene/acetabular component junction, and the liner was not disassociated from the acetabular component.All components were removed." update: the shell was revised because the surgeon didn't like the position of the component.The damaged portion of the liner was the portion that had the lot code on it therefore it was illegible.

• Brand Name: TRIDENT PSL WITH PUREFIX HA 54MM
• 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 ; EI NA
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13202867
• MDR Text Key: 286044553
• Report Number: 0002249697-2022-00043
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327037203
• UDI-Public: 07613327037203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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
• Report Date: 01/10/2022

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: 01/31/2013
• Device Model Number: 542-11-54F
• Device Catalogue Number: 542-11-54F
• Device Lot Number: JKMMTD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2021
• Initial Date FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2008
• 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: 75 YR
• Patient Sex: Male