MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-00-36F

Device Problems Device Dislodged or Dislocated (2923); No Apparent Adverse Event (3189)

Patient Problems Joint Dislocation (2374); No Code Available (3191)

Event Date 06/15/2015

Event Type  Injury  

Event Description

Patient's primary hip done elsewhere - all (b)(4).Acetabular revision to tritanium shell and liner only.Patient dislocated.Surgeon revised liner to mdm liner and poly.Right hip.

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information was requested and if it becomes available will be submitted in a supplemental report.Given to patient.

Manufacturer Narrative

Based on the provided information it has been determined that this event is associated with an off-label application.It was reported that a trident shell and liner were implanted with a competitor¿s head.It was then reported this mixed component system dislocated.The reported liner is packaged with instructions for use ((b)(4), rev h) that states, ¿warnings: do not substitute another manufacturer¿s device for any of the howmedica osteonics trident system components because design, material, or tolerance differences may lead to premature device and/or functional failure.Components of the system have been specifically designed to work together.Any such use will negate the responsibility of howmedica osteonics corp.For the performance of the resulting mixed component implant.¿ 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

Patient's primary hip done elsewhere - all zimmer.Acetabular revision to tritanium shell and liner only.Patient dislocated.Surgeon revised liner to mdm liner and poly.Right hip.

• Brand Name: TRIDENT 0° X3 INSERT 36MM ID
• 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: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4901723
• MDR Text Key: 15970085
• Report Number: 0002249697-2015-02263
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033716
• 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: 06/15/2015

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: 09/30/2019
• Device Catalogue Number: 623-00-36F
• Device Lot Number: MNMWHK
• Other Device ID Number: STRYKER LOT# MSGNN05J7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/15/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2014
• 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: 72 YR
• Patient Weight: 53