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
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the patient required a revision.
Event or Problem Description
It was reported that the patient required a revision.
Additional Manufacturer Narrative
An event regarding infection involving a trident liner was reported.The event was confirmed following visual inspection.Visual inspection was performed as part of the material analysis report (mar), which indicated: the parts were examined with the aid of a stereo microscope at magnifications up to 50x.The ceramic insert of the insert assembly had fractured into 13 pieces.Approximately 30% of the insert was returned.Damages consistent with edge chipping and metal transfer marking were observed on the insert, obscuring the fracture surfaces.These damages are consistent with contact against the titanium sleeve and ceramic head.This fracture morphology indicates the ceramic insert fractured in overload.The fracture propagated outward from the articulating surface of the ceramic insert.Damage was observed on the distal the surface of the sleeve, consistent with contact against the ceramic insert fragments and ceramic head.A material analysis has been performed.The report concluded: the ceramic insert of the alumina insert had fractured, allowing the ceramic insert fragments, ceramic head and titanium sleeve to articulate against each other.The damages observed on the three components were likely due to this articulation.Approximately 30% of the ceramic insert was returned.The ceramic insert fractured due to an overload condition, with the fracture propagating radially outward articulating surface.A continuous metal transfer ring was observed at the proximal end of the head taper, indicating proper seating between the stem trunnion and head taper.Debris was also observed on the taper of the head.The source of debris could not be determined.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.No medical records were received for review with a clinical consultant all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the reported lot.No further investigation is required at this time.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available, this investigation will be re-opened.

• Brand Name: TRIDENT ALUMINA INSERT
• Common Device Name: 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: 7886574
• Report Number: 0002249697-2018-02929
• Device Sequence Number: 14134752
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 38962104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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