MAUDE Adverse Event Report: DePuy Orthopaedics Inc US 12/14 ARTICUL 40MM M SPEC+8.5; Articuleze Head (12/14 Taper) : Hip Metal Femoral Heads

Catalog Number	136507000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/09/2026
Type of Reportable Event	Serious Injury

• Brand Name: 12/14 ARTICUL 40MM M SPEC+8.5
• 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): JTE Warsaw Mfg Site; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50947291
• Report Number: 1818910-2026-16900
• Device Sequence Number: 13374793
• Product Code: LPH
• UDI-Device Identifier: 10603295033004
• UDI-Public: (01)10603295033004(17)270630(10)3865373
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 136507000
• Device Lot Number: 3865373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/10/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 09/30/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2022
• 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: Female