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

Catalog Number 625-0T-32E

Device Problems Degraded (1153); Unstable (1667); Malposition of Device (2616)

Patient Problems Injury (2348); Ambulation Difficulties (2544)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

An event regarding instability and wear involving trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.The following devices were also listed in this report: trident psl ha cluster 50mm; cat# 542-11-50e, lot# 21866401.6.5 cancellous bone screw 30mm, cat# 2030-6530-1 ; lot# 7mmmdd.6.5 cancellous bone screw 30mm, cat# 2030-6530-1 ; lot# 7mmmdd.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

Patient had complained of subluxation and grinding of hip joint that was replaced in 2007.When surgeon operated and dislocated this joint the ceramic liner was found to have a worn superior aspect of the liner.Surgeon performed an acetabular revision.The worn liner was noticed intraoperatively, however the patient had been complaining of instability previously.

• Brand Name: TRIDENT ALUMINA INSERT
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8182673
• MDR Text Key: 130982512
• Report Number: 0002249697-2018-04085
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2012
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 22272301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2007
• 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
• Patient Age: 66 YR