MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM ID; IMPLANT

Catalog Number 623-00-32C

Device Problems Device Operates Differently Than Expected (2913); No Apparent Adverse Event (3189)

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

Event Date 05/19/2015

Event Type  Injury  

Event Description

Patients right hip was revised due to instability.Competitor cup and stryker head and liner were revised.Patient was initially implanted with stryker stem and head and zimmer liner and cup.Patient had a revision and a stryker liner was implanted.Reason for revision is unknown.".

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.Hospital policy.

Manufacturer Narrative

The reported event indicates the patient's trident liner was used in conjunction with a competitor shell which constitutes an off label combination of devices.The trident product family ifu indicates: "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." based on the provided information it has been determined that this event is associated with an off-label application.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

Patients right hip was revised due to instability.Competitor cup and stryker head and liner were revised.Patient was initially implanted with stryker stem and head and zimmer liner and cup.Patient had a revision and a stryker liner was implanted.Reason for revision is unknown.".

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4853949
• MDR Text Key: 5941991
• Report Number: 0002249697-2015-01981
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062419
• 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: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 623-00-32C
• Device Lot Number: MNEH80
• Other Device ID Number: STERILE LOT# MSGNE10D5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• 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: 91 YR
• Patient Weight: 64