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

Catalog Number	723-10-36F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: 2 of 2: "i was wondering if you can help us.We recently have 2 thr surgical site infections which occurred to patients we operated on a week apart.Both of them had very similar presentations in that the infection was very aggressive and patients became acutely unwell.They have grown the same organism called fusobacterium necrophorum which is quite unusual to be found in thrs.I have looked at the commonalities between cases and the only thing i found in common is the batch number for the liners which are: 723-10-36f; acetabular liner - poly trident; f comp 36mm (10 deg) 9n2ntj 05/01/2031.I mean this could be a very rare coincidence but we would just like to explore if there has been any recall or anything that has been flagged up in terms of contamination issues during the manufacturing process? ".
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There has been 1 similar event(s) for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

• Brand Name: TRIDENT 10 DEG X3 INSERT 36F
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 25651441
• Report Number: 0002249697-2026-00545
• Device Sequence Number: 5864751
• Product Code: JDI
• UDI-Device Identifier: 07613327339574
• UDI-Public: 07613327339574
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2026

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 Catalogue Number: 723-10-36F
• Device Lot Number: 9N2NTJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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