MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT ALUMINA INSERT; IMPLANT

Catalog Number 625-0T-32E

Device Problems Device Slipped (1584); Device Displays Incorrect Message (2591)

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

Event Date 04/04/2014

Event Type  Injury  

Event Description

It was reported that there was a revision of a right ceramic/ ceramic liner and head due to squeaking.

Manufacturer Narrative

The catalog number and lot code were not provided.The device was reported as an unknown ceramic liner.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Device evaluation and results: visual inspection was performed as part of the material analysis report (mar).Evidence of femoral neck impingement damage was observed on the rim of the sleeve component.A wear scar was observed throughout a majority of the articulating surface area.Dimensional inspection was performed as part of the mar.The results show that the diameter of the insert component did not meet the drawing requirements of a new component, most likely due to in vivo service.The mar report concluded: no material or manufacturing defects were observed on any of the components examined.Both the ceramic head and insert showed evidence of wear scars.The surface roughness, diameter and sphericity measurement results on the femoral head and insert were consistent with in-vivo service.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 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 and the operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

It was reported that there was a revision of a right ceramic/ ceramic liner and head due to squeaking.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: IMPLANT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 3778523
• MDR Text Key: 18793806
• Report Number: 0002249697-2014-01548
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 9803702
• Other Device ID Number: STERILE LOT: 0406SIRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2004
• 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
• Patient Age: 37 YR