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

Catalog Number	625-0T-32E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Injury (2348)
Date of Event	02/27/2019
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
This pi is for the revision of the patient's right hip on (b)(6) 2019.Postoperative diagnosis: patient underwent right total hip replacement 5 years ago.Patient had pain in the right hip, imaging revealed diffuse osteolysis behind the shell and the proximal femur, and the hip prosthesis appeared well fixed.Patient underwent total hip replacement (b)(6) 2019.The femoral and shell were retained, the modular head and liner were removed.Reported in cors per 1824hip.Now ((b)(6) 2019) the patient gets revised again for a hematoma, exchanging the head and liner only.
Additional Manufacturer Narrative
The following devices were also listed in this report: alumina c-taper head 32mm/0; cat# 17-3200e; lot# 51003801 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.An event regarding revision due to hematoma involving a trident liner was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
This pi is for the revision of the patient's right hip on (b)(6) 2019 postoperative diagnosis: patient underwent right total hip replacement 5 years ago.Patient had pain in the right hip, imaging revealed diffuse osteolysis behind the shell and the proximal femur, and the hip prosthesis appeared well fixed.Patient underwent total hip replacement (b)(6) 2019.The femoral and shell were retained, the modular head and liner were removed.Reported in cors per 1824hip.Now ((b)(6) 2019) the patient gets revised again for a hematoma, exchanging the head and liner only.

• 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: 8821685
• Report Number: 0002249697-2019-02649
• Device Sequence Number: 2838440
• Product Code: MRA
• UDI-Device Identifier: 04546540516848
• UDI-Public: 04546540516848
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P000013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2019

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: 09/30/2022
• Device Catalogue Number: 625-0T-32E
• Device Lot Number: 60585502
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/24/2019
• Supplement Report FDA Received Date: 09/16/2019
• 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: 50 YR
• Patient Weight: 109