MAUDE Adverse Event Report: DePuy Orthopaedics Inc US PINNACLE; Pinnacle Hip System : Hip Poly Acetabular Liners

Catalog Number	121932052
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a revision hip procedure through a direct lateral approach.The original hip replacement procedure with pinnacle trilock implants was completed 7 years previously.The patient had presented in ae with a two day history of pain, and reported hearing a ¿clunk¿ sound.The revision procedure involved the extraction of a pinnacle sector cup 52mm, a poly 52/32mm, and a 32mm ceramic head.
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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > female patient ( removed) had a revision hip procedure through a direct lateral approach in university hospital waterford (uhw) in the south east of ireland.The original hip replacement procedure with pinnacle trilock implants was completed 7 years previously in uhw.The patient had presented in ae with a two day history of pain, and reported hearing a ¿clunk¿ sound.¿photos were provided for review.- medical device incident report.The photo investigation revealed that the pinn mar neut 32idx52od has a large portion of the rim fractured.It is worth mentioning that the femoral head presents metal transfer and the acetabular cup has signs of bearing wear at the articulating section most likely caused by being in contact with the femoral head.Due to the observed conditions it is reasonable to conclude that a disassociation event occurred between the liner and the cup.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established due to there being multiple factors that may influence eccentric loading.Consideration must be given to all potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.It is highly recommended to the patient to consult with their healthcare professional for further assessment.A manufacturing record evaluation was performed for the finished device, product description: pinn mar neut 32idx52od, product code: 121932052, lot no: 8921191, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.The overall complaint was confirmed as the observed condition of the pinn mar neut 32idx52od would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = > a manufacturing record evaluation was performed for the finished device, product description: pinn mar neut 32idx52od, product code: 121932052, lot no: 8921191, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.Device history review = > a manufacturing record evaluation was performed for the finished device, product description: pinn mar neut 32idx52od, product code: 121932052, lot no: 8921191, and no non-conformances / manufacturing irregularities related to the complaint condition were identified.

• Brand Name: PINNACLE
• Common Device Name: Pinnacle Hip System : 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 orthopaedic dr.; warsaw, IN 46581 ; +1(908)386-3534
• MDR Report Key: 50083530
• Report Number: 1818910-2026-12983
• Device Sequence Number: 13316775
• Product Code: LPH
• UDI-Device Identifier: 10603295013907
• UDI-Public: (01)10603295013907(17)230930(10)8921191
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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 Expiration Date: 09/30/2023
• Device Catalogue Number: 121932052
• Device Lot Number: 8921191
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/30/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/10/2026
• Supplement Date Received by Manufacturer: 07/30/2026; 09/22/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 07/31/2026; 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2018
• 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