MAUDE Adverse Event Report: Tornier S.A.S. CEMENT RESTRICTOR DIA.24MM; Prosthesis, hip, semi-constrained, metal/polymer, cemented

Catalog Number	EBO101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Medical device site infection (4845)
Date of Event	08/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "irrigation and debridement periprosthetic infection right elbow, removal elbow implant and cement and insertion of antibiotic impregnated cement spacer and beads.During removal(cement ) portion of the medial condyle fractured fractured off and was excised.A large spacer was made and intersected into the distal humerus in beads were made inserted into the proximal ulna into the anterior soft tissues.Joint was reduced, a medium hemovac drain was placed in the depths of the wound and brought out proximally through ta lateral stab incision.Swabs was obtained intraop for aerobic gram stain and cultures and tissues samples".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.

• Brand Name: CEMENT RESTRICTOR DIA.24MM
• Common Device Name: Prosthesis, hip, semi-constrained, metal/polymer, cemented
• Manufacturer (Section D): Tornier S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): Tornier S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 50176954
• Report Number: 3000931034-2026-00635
• Device Sequence Number: 12829586
• Product Code: JDI
• UDI-Device Identifier: 03700386922053
• UDI-Public: 03700386922053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K973453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: Lay User/Patient
• Device Catalogue Number: EBO101
• Device Lot Number: 0539AY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Male