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-36G

Device Problems Metal Shedding Debris (1804); Noise, Audible (3273)

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

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Sales rep reported, hip was making noise.Surgeon reported metallosis.

Manufacturer Narrative

Additional information: returned to manufacturer on an event regarding audible noise involving a trident liner was reported.The event was not confirmed.Device evaluation and results: visual inspection: a visual inspection was carried out by a material analysis engineer noted the following: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.Metal transfer markings and wear scars were observed on the head.A continuous metal transfer ring was observed at the proximal end of the taper, indicating proper seating between the head taper and stem trunnion.Dimensional inspection: not performed as this event does not represent a dimensional related issue.Functional issue: not performed as this event does not represent a functional issue a material analysis has been performed.This reported concluded metal transfer markings and a wear scar was observed on the head.Damage consistent with the explantation process and impingement were observed on the shell.No material or manufacturing defects were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices in the reported lot were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: 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.Further information such as pre- and post-operative x-rays,patient history and follow-up notes are needed to complete the investigation for determining root cause.If additional information becomes available, this investigation will be reopened.

Event Description

Sales rep reported, hip was making noise.Surgeon reported metallosis.

• 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: rita intorrella ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6405979
• MDR Text Key: 69993451
• Report Number: 0002249697-2017-00919
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/23/2017

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: 04/30/2011
• Device Catalogue Number: 625-0T-36G
• Device Lot Number: 18165801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2006
• 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