MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENTII HEMI CLUSTER44B; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	702-11-44B
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Periprosthetic fracture (4902)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was provided: hairline acetabular fracture tracking up towards checkpoint position.Noticed by the surgeon followed mako tha cup impaction.Surgeon assessed cup stability and was happy to used x1 low profile hex screw for additional fixation.5 minute delayed while we opened the screw tray and added a screw for additional fixation.No other adverse consequences reported.Tha 4.1.Rob2608.No further patient details available.
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Additional Manufacturer Narrative
Reported event: an event regarding intraoperative fracture involving a trident ii shell 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 remains implanted.-clinician review: insufficient information was provided to support a medical review.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that 'hairline acetabular fracture tracking up towards checkpoint position.Noticed by the surgeon followed mako tha cup impaction.Surgeon assessed cup stability and was happy to used x1 low profile hex screw for additional fixation.5 minute delayed while we opened the screw tray and added a screw for additional fixation.No other adverse consequences reported.Tha 4.1.Rob2608.' the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report and/or photographs/video of the reported event are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
No additional information.

• Brand Name: TRIDENTII HEMI CLUSTER44B
• 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-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: alessandra chavez ; 3365 enterprise ave; weston, FL 33331 ; 9546280700
• MDR Report Key: 23543338
• Report Number: 0002249697-2025-01331
• Device Sequence Number: 9683718
• Product Code: JDI
• UDI-Device Identifier: 07613327380897
• UDI-Public: 07613327380897
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K250989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: 702-11-44B
• Device Lot Number: 27331551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2024
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Female