MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT X3 ECCENTRIC 10 32MM ID; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	663-10-32D
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Insufficient Information (4580)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information in this report was provided by stryker orthopaedics legal affairs department.No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Additional devices listed in this event: catalog: 2030-6530-1, description: 6.5 cancellous bone screw 30mm, lot: mnpt4l.Catalog: 6570-0-232, description: delta v-40 ceramic head 32/+4, lot: 47552102.Catalog: 502-03-50d, description: primary tritanium hemi cluster hole cup 50mm, lot: mnpt4l.Catalog: 6720-0435, description: size 4 accolade ii 132 deg, lot: 50062203.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Not returned.
Event or Problem Description
This pi is for the right hip.It was reported by the attorney, through the filing of a legal claim, that the patient underwent a right total hip arthroplasty on (b)(6) 2015 where she was implanted with a stryker hip system.Its further alleged that the hip failed and was revised on (b)(6) 2018.
Additional Manufacturer Narrative
Corrected data: it was discovered that the selection for b2 was inadvertently missed during the submission of the initial report.B2 has been updated with the appropriate information.H3 other text : device not returned.
Event or Problem Description
*this pi is for the right hip.It was reported by the attorney, through the filing of a legal claim, that the patient underwent a right total hip arthroplasty on (b)(6) 2015 where she was implanted with a stryker hip system.Its further alleged that the hip failed and was revised on october (b)(6).

• Brand Name: TRIDENT X3 ECCENTRIC 10 32MM 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: 8148500
• Report Number: 0002249697-2018-03961
• Device Sequence Number: 16495500
• Product Code: LPH
• UDI-Device Identifier: 07613327024838
• UDI-Public: 07613327024838
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 04/30/2019
• Device Model Number: 663-10-32D
• Device Catalogue Number: 663-10-32D
• Device Lot Number: MNE10K
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 11/24/2020
• 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: 48 YR