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

Model Number	625-0T-32F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is being performed in an attempt to identify the cause of the event.Should additional information become available it will be reported in a supplemental report.
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of clicking.Intra-operatively, it was noted that the neck of the stem was impinging on the titanium sleeve of the ceramic liner.The shell, liner, and head were revised.There are no allegations against the head or shell.Patient was revised to a trident shell with an mdm/adm liner construct and new femoral head.Rep reported that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
An event regarding audible noise involving a trident liner was reported.The event was not confirmed.Method & results: device evaluation and results: could not be performed as no device associated with the event were returned or made available for identification or evaluation.Clinician review: no medical records were received for review with a clinical consultant.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 events for this lot.Conclusions: it was reported that patient is experiencing creaking, squeaking, squealing and growling noises and discomfort.The event could not be confirmed nor could the root cause determined due to the minimal information received.The provided medical information was submitted to a consulting clinician who deemed the information insufficient to confirm the noise related 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.
Event or Problem Description
It was reported that the patient's left hip was revised after patient complaint of clicking.Intra-operatively, it was noted that the neck of the stem was impinging on the titanium sleeve of the ceramic liner.The shell, liner, and head were revised.There are no allegations against the head or shell.Patient was revised to a trident shell with an mdm/adm liner construct and new femoral head.Rep reported that no further information will be released by the hospital or surgeon.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9383313
• Report Number: 0002249697-2019-03889
• Device Sequence Number: 2207694
• Product Code: MRA
• UDI-Device Identifier: 04546540516855
• UDI-Public: 04546540516855
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1999
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2004
• Device Model Number: 625-0T-32F
• Device Catalogue Number: 625-0T-32F
• Device Lot Number: 570616
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 102