MAUDE Adverse Event Report: DePuy Orthopaedics Inc US DURALOC; Duraloc Implant : Hip Poly Acetabular Liners

Catalog Number	122032152
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury

• Brand Name: DURALOC
• Common Device Name: Duraloc Implant : Hip Poly Acetabular Liners
• 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 orthpaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50795302
• Report Number: 1818910-2026-16009
• Device Sequence Number: 18769360
• Product Code: LPH
• UDI-Device Identifier: 10603295015536
• UDI-Public: (01)10603295015536
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 122032152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/16/2026
• 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: Unknown