MAUDE Adverse Event Report: DePuy Orthopaedics Inc US ARTICULEZE M HEAD 36MM +1.5; Articuleze Head (12/14 Taper) : Hip Metal Femoral Heads

Catalog Number	136551000
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury

• Brand Name: ARTICULEZE M HEAD 36MM +1.5
• Common Device Name: Articuleze Head (12/14 Taper) : Hip Metal Femoral Heads
• Manufacturer (Section D): DePuy Orthopaedics Inc US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer (Section G): JJMSZ Plant for Stk. & N-Stk.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu 21512 6; CH 215126
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50847490
• Report Number: 1818910-2026-16312
• Device Sequence Number: 10053555
• Product Code: JDI
• UDI-Device Identifier: 10603295033912
• UDI-Public: (01)10603295033912(17)310131(10)D26021343
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 136551000
• Device Lot Number: D26021343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/21/2026
• 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