MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRIDENT 0 DEG X3 INSERT 36D; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	723-00-36D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a total hip procedure completed with mako.Afterward surgery patient complained of pain, so surgeon referred patient to do a postoperative ct scan to investigate.Upon reviewing the ct, surgeon noticed a unknown debris was found between the biolox ceramic head and the shell, although surgeon does not think this is directly cause the pain.
Additional Manufacturer Narrative
The following devices were also listed in this report: tridentii tritanium cluster48d; cat # 702-04-48d; lot # 35812951, delta v-40 ceramic head 36/+2,5; cat # 6570-0-536; lot # 37053054, high insignia collared hip stem; cat # 7000-6602; lot # 32948152, reciprocating blade heavy duty, offset (77.5 x 1.23 x 11.0mm); cat # 0277096326; lot # 25259027.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.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.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.

• Brand Name: TRIDENT 0 DEG X3 INSERT 36D
• 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: 25511436
• Report Number: 0002249697-2026-00515
• Device Sequence Number: 10543928
• Product Code: JDI
• UDI-Device Identifier: 07613327296990
• UDI-Public: 07613327296990
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K182468
• 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): 06/15/2026

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: 723-00-36D
• Device Lot Number: D43YN7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• 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 Sex: Unknown