MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ECCENTRIC 10° 36MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	663-10-36G
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/12/2019
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
Patient's daughter called stating her father had a left hip revision due to a dislocation.Update 10 september, 2019: medical review noted from an operative report on (b)(6) 2019 "a revision of the left anterior total hip arthroplasty was performed for a pre- and post-operative diagnosis of ¿failed left total hip arthroplasty¿.The operative report describes general anesthesia and an anterior approach.The findings note, ¿gross trunnion wear, extensive metallosis and poly wear¿.The operative report states, ¿¿ had no problems until he woke up with pain and unable to ambulate ¿ well-fixed and well positioned femoral and acetabular components ¿ ball disassociated from trunnion ¿ this operative report also notes that "intraoperatively an anterior cortical fracture was noted and treated with a 1.8mm cable.Otherwise, uncomplicated surgery was described." the medical review concluded the following: no x-rays demonstrating disassociation of the femoral head and trunnion deformity are available for review.No examination of the explanted components and no surgical histopathology confirming metallosis or altr are available.Based upon the information available for review, no determination can be made for the cause of the disassociation and trunnion deformity described in the event and revision surgery operative report, which occurred after eleven years and three months post primary total hip arthroplasty.Update: as per patient's daughter, father could not put any wearing bearing on his hip and could not walk.Patient was transferred to emergency room and they couldn't determine what was wrong with the patient, the patient was then transferred to another hospital and he was told that he needed surgery.After the surgery, the surgeon stated they had to do a revision because there was a problem with the implants.Patient's daughter stated that they were told her fathers implant were part of recall.

• Brand Name: TRIDENT X3 ECCENTRIC 10° 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: 9183728
• Report Number: 0002249697-2019-03462
• Device Sequence Number: 16778482
• Product Code: LPH
• UDI-Device Identifier: 07613327024937
• UDI-Public: 07613327024937
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/12/2019

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: 04/30/2010
• Device Catalogue Number: 663-10-36G
• Device Lot Number: 1ZEPSA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: 88 YR
• Patient Weight: 68