MAUDE Adverse Event Report: DePuy Orthopaedics Inc US PINNACLE POROCOAT; Pinnacle Hip System : Hip Metal Acetabular Cups

Catalog Number	121722052
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Unspecified Musculoskeletal problem (4535)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury

• Brand Name: PINNACLE POROCOAT
• Common Device Name: Pinnacle Hip System : Hip Metal Acetabular Cups
• 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: 50518546
• Report Number: 1818910-2026-14790
• Device Sequence Number: 21134638
• Product Code: LPH
• UDI-Device Identifier: 10603295009825
• UDI-Public: (01)10603295009825(17)321130(10)M1834R
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K001534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121722052
• Device Lot Number: M1834R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/18/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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
• Patient Race: White