MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 32MM ID E; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	623-00-32E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by stryker sales rep that patient is required for revision due to infection.
Additional Manufacturer Narrative
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: device name#trident cup 50 ; cat#unk_jr ; lot#unknown; device name#metal head 32 ; cat#unk_jr ; lot#unknown; device name# exeter 35.505801351; cat#0580-1-351 ; lot#5727965.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
Additional Manufacturer Narrative
An event regarding infection involving an trident liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: the reported device was not returned however photos were provided for review.A review of the provided photos indicated recently explanted devices covered in blood and tissue.No conclusive decision can be made.-clinician review: a review with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent a hybrid total hip arthroplasty as described above since i was able to see x-rays with the implant in place.I can confirm that the patient underwent explantation of the prostheses since i was able to see photographs of the explanted implants.I do not have an operation report, office notes or post revision x-rays.Root cause analysis: the cause of this event cannot be determined with certainty.Causes of infection, presumably late given the x-ray changes are multifactorial.It is unlikely that this would be due to contamination at the time of surgery but most likely due to seeding of the hip joint from a remote area that may have experienced a bacteremia.Patient factors could contribute especially if the patient was immunocompromised, had poor nutrition, poor dentition, etc.I would not attribute any causality to the implants themselves." -product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot or sterile lot referenced.Conclusions: it was reported that the patient was revised due to infection.Visual inspection: the reported device was not returned however photos were provided for review.A review of the provided photos indicated recently explanted devices covered in blood and tissue.No conclusive decision can be made.A review with a clinical consultant indicated "confirmation of event: i can confirm that the patient underwent a hybrid total hip arthroplasty as described above since i was able to see x-rays with the implant in place.I can confirm that the patient underwent explantation of the prostheses since i was able to see photographs of the explanted implants.I do not have an operation report, office notes or post revision x-rays.Root cause analysis: the cause of this event cannot be determined with certainty.Causes of infection, presumably late given the x-ray changes are multifactorial.It is unlikely that this would be due to contamination at the time of surgery but most likely due to seeding of the hip joint from a remote area that may have experienced a bacteremia.Patient factors could contribute especially if the patient was immunocompromised, had poor nutrition, poor dentition, etc.I would not attribute any causality to the implants themselves." 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.Further information such as pathology reports, pre- and post-operative x-rays and the revision 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
It was reported by stryker sales rep that patient is required for revision due to infection.

• Brand Name: TRIDENT 0 DEG X3 INSERT 32MM ID E
• 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 NJ NA ; EI NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20063109
• Report Number: 0002249697-2024-01166
• Device Sequence Number: 7784967
• Product Code: LPH
• UDI-Device Identifier: 07613327039450
• UDI-Public: 07613327039450
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K033716
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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: 07/31/2017
• Device Catalogue Number: 623-00-32E
• Device Lot Number: 41064301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2012
• 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 Sex: Unknown