MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ACET WINDOW TRIAL 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2208-2054

Device Problems Break (1069); Fracture (1260); Material Distortion (2977)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Trial threads stripped / broke off of trial during extraction of trial from patient during surgery.To extract item from patient, item was removed with the aid of high speed burr to cut portion of item.This took time causing delay of surgical procedure.

Manufacturer Narrative

An event regarding thread damage involving a trident trial was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the subject device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: not performed as the device was not properly identified.Complaint history review: not performed as the device was not properly identified.Conclusions: it was reported that "trial threads stripped / broke off of trial during extraction of trial from patient during surgery.To extract item from patient, item was removed with the aid of high speed burr to cut portion of item." the exact cause of the event could not be determined as device was not returned.No further investigation for this event is possible at this time as no devices and / or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Trial threads stripped / broke off of trial during extraction of trial from patient during surgery.To extract item from patient, item was removed with the aid of high speed burr to cut portion of item.This took time causing delay of surgical procedure.

• Brand Name: TRIDENT ACET WINDOW TRIAL 54MM
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7157872
• MDR Text Key: 96224210
• Report Number: 0002249697-2018-00022
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2208-2054
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR