MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 NEUT 28IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122128450
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11: additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
Event or Problem Description
It was reported the liner has been worn down and spanned out after ten (10) months.The acetabulum was re-reamed and implants were replaced.The procedure was completed with no delay or consequences to the patient reported.
Additional Manufacturer Narrative
Product complaint #(b)(4) investigation summar consultant surgeon has revised a 10 months old thr with a +4 liner insitu that has been worn down and span out.Rereamed the acetabulum and implants gription cup with pinnacle neutral liner.The product was not returned to depuy synthes; however, photos were provided for review.(b)(4) product report of worn down and span out +4 pinnacle liner on a 10 months old thr.The photo investigation revealed that the altrx +4 neut 28idx50od appears to have some anti-rotation device (ard) tabs sheared off and seems to be slightly deformed at the rim, also presents signs of bearing wear.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.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 records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the altrx +4 neut 28idx50od would have contributed to the complained device 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 records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.Added: d10.

• Brand Name: ALTRX +4 NEUT 28IDX50OD
• Common Device Name: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23729106
• Report Number: 1818910-2025-21278
• Device Sequence Number: 13419753
• Product Code: LPH
• UDI-Device Identifier: 10603295016076
• UDI-Public: (01)10603295016076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 122128450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN HIP ACETABULAR CUP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown