MAUDE Adverse Event Report: DePuy Orthopaedics Inc US APEX; Pinnacle Hip System : Hip Acetabular Augment

Catalog Number	124603000
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Metal Related Pathology (4530); Unspecified Tissue Injury (4559); Bone Notching (4890)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient underwent a left total hip replacement in which depuy pinnacle components were implanted.Following the procedure, the patient experienced ongoing hip pain, difficulty bearing weight, and mechanical symptoms including catching and locking of the hip.On (b)(6) 2023, the patient underwent a left hip revision surgery due to failure of the implanted components.The patient experienced a popping sensation in the left hip following a previous left total hip arthroplasty.The patient also reported sustaining a fall after slipping two days prior to evaluation.Assessment revealed hip instability with lateral stress, and minimal bone loss was noted following removal of the acetabular cup.During the revision procedure, the surgeon confirmed failure of the depuy components.The operative findings included a failed titanium-to-titanium acetabular liner, metallosis, and metal wear of the acetabular component.The surgeon observed significant metallosis with darkened tissues and darkened motor-oil-color joint fluid.The gluteus minimus had significant metallosis and degeneration.The capsule had an inner metallosis rind formation.The metallosis issues were debrided and tissue was sent to microbiology and pathology.The acetabular liner was found to be dissociated inferiorly, with sheared locking tabs, allowing the ceramic femoral head to articulate directly against the metal inner shell of the acetabular cup.As a result of this metal-on-ceramic contact, there was significant wear to the acetabular component and metal striping of the ceramic femoral head.The femoral stem remained stable.This failure permitted direct contact between the ceramic femoral head and the metal acetabular cup, generating metal debris and metal ions that were released into the patient's surrounding tissues.The presence and toxicity of these metal ions were evidenced by the extensive metallosis observed intraoperatively, requiring surgical debridement and removal of contaminated tissue.As a direct and/or proximate result of the defective nature of the depuy components, specifically the failure of the locking mechanism of the pinnacle acetabular cup which caused the polyethylene liner to dissociate, the patient has suffered physical and mental pain, disability, disfigurement, loss of enjoyment of life and lifestyle, economic losses, and medical expenses, as further described herein.Affected side: left hip.
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.

• Brand Name: APEX
• Common Device Name: Pinnacle Hip System : Hip Acetabular Augment
• 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: 50055855
• Report Number: 1818910-2026-12829
• Device Sequence Number: 13421769
• Product Code: LPH
• UDI-Device Identifier: 10603295019688
• UDI-Public: (01)10603295019688(17)290531(10)D19060637
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• 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: 124603000
• Device Lot Number: D19060637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2019
• 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