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

Model Number	723-10-36F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hip revision due to infection.Accolade ii stem removed, trident psl cup, liner and screws removed.
Additional Manufacturer Narrative
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 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.Catalog numbers and lot codes of other devices listed in this report: 542-11-54f trident psl cluster cup lot 89161303 6721-0330 accolade ii 127* size 3 lot 92335701 2030-6525-1 torx screw qty 2 lot e24mv1 6570-0-036 biolox delta ceramic 36mm -5mm head lot 69283001 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a trident liner was reported.The event was not confirmed.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-device history review: a review of the device history records indicates devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been 3 other similar events for the sterile lot referenced related to infection.Conclusion: all stryker products sold as sterile are validated to a minimum sterility assurance level (sal) of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Additional information including pathology reports, operative reports, progress notes, x-rays 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.The following device were also listed in this report: device name#2030-6525-1 torx screw ; cat#2030-6525-1 ; lot#e24mv1 it cannot be determined which, if any of these device may have caused or contributed to the patient's experience.
Event or Problem Description
Hip revision due to infection.Accolade ii stem removed, trident psl cup, liner and screws removed.

• Brand Name: TRIDENT 10 DEG X3 INSERT 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: arokiya raj ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15238421
• Report Number: 0002249697-2022-01184
• Device Sequence Number: 6456862
• Product Code: LPH
• UDI-Device Identifier: 07613327339574
• UDI-Public: 07613327339574
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K182468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

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 Model Number: 723-10-36F
• Device Catalogue Number: 723-10-36F
• Device Lot Number: VR047R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 90 KG