MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE

Catalog Number 625-0T-32F

Device Problems Corroded (1131); Material Discolored (1170); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 11/16/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Primary tha surgery using ceramic liner was performed on (b)(6) 2007.The revision surgery was performed on (b)(6) 2016 because the patient complained of squawking.During the revision, the surgeon found a discoloration like a corrosion on the metal of the ceramic liner.The corrosion investigation has been requested.

Manufacturer Narrative

An event regarding squeaking and corrosion involving an trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: visual inspection: the returned device showed no evidence of discoloration or corrosion.Some damage consistent with explantation damage was observed on the rim of the liner.-medical records received and evaluation: a medical review was not performed because no medical information was provided.-device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: review indicated there have been no other similar events for the reported lot.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, patient history, progress notes and x-rays are needed to fully investigate the event.If further information becomes available this investigation will be re-opened.

Event Description

Primary tha surgery using ceramic liner was performed on (b)(6) 2007.The revision surgery was performed on (b)(6) 2016 because the patient complained of squawking.During the revision, the surgeon found a discoloration like a corrosion on the metal of the ceramic liner.The corrosion investigation has been requested.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCE
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6174146
• MDR Text Key: 62367068
• Report Number: 0002249697-2016-03919
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• PMA/PMN Number: P000013
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2012
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 23502802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2016
• Initial Date FDA Received: 12/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2007
• 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): Hospitalization; Required Intervention