MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT PSL HA SOLID BACK 50MM; IMPLANT

Catalog Number 540-11-50E

Device Problems Fitting Problem (2183); Scratched Material (3020)

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

Event Date 08/27/2014

Event Type  malfunction  

Event Description

When dr impacted the ceramic liner into the trident psl solid shell it wasn't fully seated so he tried to remove it with a bristow elevator, it did not disengage so he used the trident liner removal tool, as he was trying to disengage the liner the trident shell then started to move so he decided to impact the liner again.After impacting the liner he noticed what looked like a scratch on the ceramic so he removed both the shell and liner.Replaced the solid shell with a psl cluster shell, with one 30mm screw and a replacement ceramic liner.

Manufacturer Narrative

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

Manufacturer Narrative

Implant and explant date updated.An event regarding seating/locking issues involving a trident psl ha solid back 50mm was reported.The event was confirmed.A device history review indicated that the specified lot was accepted into final stock with no reported discrepancies.A complaint history review indicated that there have not been any other events for the specified lot.The reported event involves an attempt to remove the liner that was not fully seated.This caused the shell to move, so the doctor impacted the liner again.After impacting the surgeon noticed a scratch on the liner and removed both the shell and the liner.It is likely that the initial attempt to remove the liner from the shell created the reported scratch marks.Visual inspection of the returned devices clearly shows that the liner is malpositioned within the shell.This indicates that the liner was malpositioned before impaction.Therefore the cause of this event is user related.

Event Description

When dr impacted the ceramic liner into the trident psl solid shell it wasn't fully seated so he tried to remove it with a bristow elevator, it did not disengage so he used the trident liner removal tool, as he was trying to disengage the liner the trident shell then started to move so he decided to impact the liner again.After impacting the liner he noticed what looked like a scratch on the ceramic so he removed both the shell and liner.Replaced the solid shell with a psl cluster shell, with one 30mm screw and a replacement ceramic liner.

• Brand Name: TRIDENT PSL HA SOLID BACK 50MM
• 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: niku kasmai ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4109475
• MDR Text Key: 4759403
• Report Number: 0002249697-2014-03588
• 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: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 540-11-50E
• Device Lot Number: 42495801
• Other Device ID Number: STERILE LOT 1301KCM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2013
• 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: 59 YR