MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM REVISION ACETABULAR; IMPLANT

Catalog Number 509-02-58F

Device Problems Device Slipped (1584); No Apparent Adverse Event (3189)

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

Event Date 10/24/2012

Event Type  Injury  

Event Description

This was reported as an ae as part of the (b)(6) clinical study, and was reported as uncertain if related to the device.The patient had asymptomatic acetabular component loosening.The patient was terminated from the study (b)(6) 2015 due to sciatica.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned due to hospital policy.Additional information has been requested and if received, will be provided in the supplemental report.Not returned to manufacturer.

Manufacturer Narrative

A stryker tritanium shell, dome hole plug, trident liner, gap plate screws, and dall miles cables were mated with a non stryker biomet femoral stem and head.This combination is not sanctioned by stryker and as such is considered an off label application of the devices.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This was reported as an ae as part of the tritanium revision acetabular shell clinical study, and was reported as uncertain if related to the device.The patient had asymptomatic acetabular component loosening.The patient was terminated from the study (b)(6) 2015 due to sciatica.

• Brand Name: TRITANIUM REVISION ACETABULAR
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4860783
• MDR Text Key: 5851525
• Report Number: 0002249697-2015-02032
• Device Sequence Number: 1
• Product Code: LPH
• 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,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/28/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: 509-02-58F
• Device Lot Number: PNKMAE
• Other Device ID Number: STERILE LOT# MSH0803D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2008
• 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): Other
• Patient Age: 44 YR