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-32E

Device Problem Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 04/02/2018

Event Type  Injury  

Manufacturer Narrative

Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other events for the reported lot.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Patient had a right total hip replacement on (b)(6) 2008.She recently came back to dr.(b)(6) complaining of clunking in her hip.She was scheduled for revision.The operation was performed.All components were stable, well positioned and in good condition.The ceramic liner and ceramic head were exchanged for a new ceramic head and sleeve and a new poly liner.The operation was completed successfully.

Event Description

Patient had a right total hip replacement on (b)(6)2008.She recently came back to the doctor complaining of clunking in her hip.She was scheduled for revision.The operation was performed.All components were stable, well positioned and in good condition.The ceramic liner and ceramic head were exchanged for a new ceramic head and sleeve and a new poly liner.The operation was completed successfully.

Manufacturer Narrative

An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned -clinician review: a review of the provided medical records by a clinical consultant stated the following comment: review of these records confirms a revision tha occurred, however, the root cause cannot be determined as insufficient information was available -device history review: review of the device history records indicates that all devices 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.Additional information, including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.Stryker orthopaedics conducted an investigation to evaluate reports of audible noise during motion involving trident ceramic bearing systems.An analysis of the overall complaint data, and additional information concerning this evaluation is documented in capa.In capa, stryker orthopaedics determined that the root cause of squeaking is associated with repetitive edge loading of the femoral bearing against the edge of the ceramic insert.Edge loading, the mechanism by which a wear scar (stripe wear) is generated on the ceramic bearing surfaces, is primarily associated with impingement, joint laxity, and implant orientation.Stryker orthopaedics created separate and distinct surgical techniques, one for the trident psl shell and one for the trident hemispherical shell in order to clarify the different reaming techniques recommended to achieve initial fixation.In addition, language was added to instruct users to check shell position/orientation and to assess impingement during range of motion checks.Corrective actions were fully implemented as of september 2009.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.

• 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
• MDR Report Key: 7459193
• MDR Text Key: 106455306
• Report Number: 0002249697-2018-01237
• 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
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

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: 09/30/2012
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 24372802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 06/15/2018
• Supplement Dates FDA Received: 07/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR
• Patient Weight: 124