MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ELEVATED RIM 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	643-00-36F
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional 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 similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that a revision surgery is scheduled for the patient's right hip on (b)(6) 2020 due to the head and part of the stem breaking off from the rest of the stem.Update: "surgeon revised liner, do to wear and time frame the cup had been in patient.".
Event or Problem Description
It was reported that a revision surgery is scheduled for the patient's right hip on (b)(6) 2020 due to the head and part of the stem breaking off from the rest of the stem.Update: "surgeon revised liner, do to wear and time frame the cup had been in patient.".
Additional Manufacturer Narrative
An event regarding wear involving trident liner was reported.The event was confirmed on the basis of visual inspection.Method & results: -device evaluation and results: visual inspection - as per the attached picture of explanted liner in communication log, liner appears to be in damaged state with various scratches in the inner surface and blackening at its outer circular surface area.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: a review of the provided medical records by a clinical consultant rejected and stated the following comment: rejected for medical review - x-ray confirms disassociation and fracture at base of the trunnion of the stem, need additional information; revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.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.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, 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.

• Brand Name: TRIDENT X3 ELEVATED RIM 36MM ID
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9898067
• Report Number: 0002249697-2020-00631
• Device Sequence Number: 2818518
• Product Code: LPH
• UDI-Device Identifier: 07613327025101
• UDI-Public: 07613327025101
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 11/30/2013
• Device Model Number: 643-00-36F
• Device Catalogue Number: 643-00-36F
• Device Lot Number: MER4XE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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: 80 YR
• Patient Weight: 98