MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII TRITANIUM MULTI 56F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	709-04-56F
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	08/09/2022
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The following devices were also listed in this report: cat# 7030-6525; 6.5mm low profile hex screw 25mm; lot# wtvj.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Event or Problem Description
It was reported that after a revision of unknown components in the patient's right hip, the screw was found to have passed through the shell.Surgeon plans to revise the patient (b)(6) 2022 as the shell spun out.Surgeon is an experienced (over 30 years) in hip cases.Rep is not aware if there was anything unusual about the implantation of the screw (angle, etc.).
Additional Manufacturer Narrative
An event regarding malposition involving a trident ii shell was reported.The event was not confirmed.Method & results: product evaluation and results: no product was returned for evaluation however photographs were provided for review.The photographs show a recently explanted shell.Blood and biological matter is visible on the device.Damage is visible to the screw hole on the shell.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate 20 devices were manufactured and accepted into final stock on 25 september 2021 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the event could not be confirmed as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays, 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.There is no indication to suggest a product nonconformity or unanticipated hazard.
Event or Problem Description
It was reported that after a revision of unknown components in the patient's right hip, the screw was found to have passed through the shell.Surgeon plans to revise the patient (b)(6) 2022 as the shell spun out.Surgeon is an experienced (over 30 years) in hip cases.Rep is not aware if there was anything unusual about the implantation of the screw (angle, etc.).

• Brand Name: TRIDENTII TRITANIUM MULTI 56F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15354379
• Report Number: 0002249697-2022-01298
• Device Sequence Number: 1726078
• Product Code: LPH
• UDI-Device Identifier: 07613327343977
• UDI-Public: 07613327343977
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171768
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 09/30/2026
• Device Model Number: 709-04-56F
• Device Catalogue Number: 709-04-56F
• Device Lot Number: 85748301A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 09/05/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male