MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 10° X3 INSERT 36MM ID; IMPLANT

Catalog Number 623-10-36F

Device Problems Use of Device Problem (1670); Delamination (2904); Misassembly by Users (3133)

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

Event Date 04/15/2015

Event Type  malfunction  

Event Description

It was reported that upon attempt to insert liner, impaction was unsuccessful.A partial delamination of the locking bead was noticed.The decision was made to use a new liner.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding seating locking involving a trident 10° x3 insert was reported.The event was confirmed.Method and results: device evaluation and results: the subject liner was returned in used condition with damages consistent with the reported implantation attempt.Minor indentation damage is noted all around the back side of the device on both the hemispherical surface and the locking face.This damage appears consistent with debris trapped between the liner and shell.Medical records received and evaluation: medical records or x-rays were not provided for analysis.Device history review: review of the device history records indicate that all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for the lot referenced.Conclusions: the investigation determined the likely root cause of the event to be debris trapped between the mating faces of the liner and shell during insertion and attempted locking.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that upon attempt to insert liner, impaction was unsuccessful.A partial delamination of the locking bead was noticed.The decision was made to use a new liner.

• Brand Name: TRIDENT 10° 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: keyla navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4765221
• MDR Text Key: 5779005
• Report Number: 0002249697-2015-01517
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 623-10-36F
• Device Lot Number: 4M72X7
• Other Device ID Number: STERILE LOT: MSGNT16E4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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): Other