MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 62MM; IMPLANT

Catalog Number 540-11-62H

Device Problem Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2014

Event Type  malfunction  

Event Description

Having reamed line to line surgeon impacted trident psl solid cup 62mm, 540-11-62h, into the patient's acetabulum.This fitted firmly with no apparent micromotion.Surgeon then attempted to impact a polyethylene insert, 623-10-32h, into the shell; however, this failed to lock into the shell.Another polyethylene liner of the same size was opened and impacted into the shell.Again this failed to lock in.The surgeon was obliged to remove the shell replacing it with a trident psl cluster shell 62mm 542-11-62h which he impacted into the acetabulum, using two screws to enhance fixation.The poly which failed to lock into the original solid shell locked into this cluster shell no problem.The surgeon felt the original solid shell had deformed because of the patient's hard bone.He asked for this to be investigated by stryker.

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

The patient is (b)(6).An event regarding alleged seating/locking issue involving a trident shell and a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: insufficient information was received for review with a clinical consultant.-device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the reported lot.Conclusions: the exact cause of the event could not be determined, because insufficient information was received.Further information such as return of device, operative reports, x-rays, patient history & follow-up notes are needed to investigate this event further.

Event Description

Having reamed line to line surgeon impacted trident psl solid cup 62mm, 540-11-62h, into the patient's acetabulum.This fitted firmly with no apparent micromotion.Surgeon then attempted to impact a polyethylene insert, 623-10-32h, into the shell however this failed to lock into the shell.Another polyethylene liner of the same size was opened and impacted into the shell.Again this failed to lock in.The surgeon was obliged to remove the shell replacing it with a trident psl cluster shell 62mm 542-11-62h which he impacted into the acetabulum, using two screws to enhance fixation.The poly which failed to lock into the original solid shell locked into this cluster shell no problem.The surgeon felt the original solid shell had deformed because of the patient's hard bone.He asked for this to be investigated by stryker.

• Brand Name: TRIDENT PSL HA SOLID BACK 62MM
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4356309
• MDR Text Key: 16181891
• Report Number: 0002249697-2014-04882
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K983382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 540-11-62H
• Device Lot Number: 42082201
• Other Device ID Number: STERILE LOT 1212JCM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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): Other
• Patient Age: 65 YR
• Patient Weight: 100