MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 623-00-32D

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During surgery, the x3 liner did not be attached to the trident cup.The surgeon used other liner and finished the surgery.

Manufacturer Narrative

An event regarding seating/locking issue involving a trident liner was reported.The event was not confirmed.Method and 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: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

During surgery, the x3 liner did not be attached to the trident cup.The surgeon used other liner and finished the surgery.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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 colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5547670
• MDR Text Key: 41904393
• Report Number: 0002249697-2016-01089
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: K033716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2016

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: 01/31/2021
• Device Catalogue Number: 623-00-32D
• Device Lot Number: 1J32K4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2016
• Initial Date FDA Received: 04/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/04/2016
• 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