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

Catalog Number	122132048
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that altrx neut 32idx48od was associated with liner disassociation identified on x-ray during a planned revision arthroplasty.Intra-operatively, the liner was described as worn and warped, and the ceramic femoral head exhibited substantial wear.The acetabular cup appeared intact, and the screw was flush.Patient harm was reported, and revision surgery was required; as a result, the head and liner were revised, and a new lipped liner and ts head were implanted.The implant products involved were explanted; the altrx neut 32idx48od and unk hip femoral head ceramic were discarded, and the unk hip acetabular cup pinnacle was retained by the customer.
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: PINNACLE ALTRX
• 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: 50884247
• Report Number: 1818910-2026-16525
• Device Sequence Number: 9791919
• Product Code: LPH
• UDI-Device Identifier: 10603295016090
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• 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: 122132048
• Device Lot Number: M50K92
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2023
• 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