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

Catalog Number	121722058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Date of Event	08/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented acutely at ed on 17/8/26 unable to weight-bear on right side 10 years post tha following a deep flexion movement (no fall).The patient was taken to theatre on 19/8/26 and revision of liner and head was performed.A 56 x 36 lipped altrx liner was implanted and a 1.5mm delta ts head.The surgeon was confident there was no damage to inner surface of cup insitu and decided to leave in place.
Additional Manufacturer Narrative
Product complaint # (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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): Cork Mfg & Material Warehouse; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50713383
• Report Number: 1818910-2026-15420
• Device Sequence Number: 10599147
• Product Code: LPH
• UDI-Device Identifier: 10603295009856
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K000306
• 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
• Report Date (Section B): 09/10/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 121722058
• Device Lot Number: 8292708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2021
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 191 LB