MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX +4 10D 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132148
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
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.
Event or Problem Description
It was reported the patient underwent a left hip arthroplasty.During investigation of the returned product it was noted the revision was likely due to a fractured liner that has disassociated from the cup.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary- litigation complaint received ad 30 apr 2025.Patient underwent a left hip arthroplasty with depuy implanted.Doi: unknown dor: unknown left hip the product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the altrx +4 10d 32idx48od exhibited a rim fracture that encompasses approximately 40% of its circumference.Examination of the fracture surface revealed multiple fatigue fracture initiation regions, characterized by beach markings consistent with fatigue fractures.These markings indicate initiation points at the outer diameter of the liner.The fracture location corresponds with edge loading of the liner.No evidence of embedded debris, third-body wear, pitting, oxidation, delamination, or crazing was found on the liner.Based on these findings, the observed wear pattern, and damage near the edge imply that edge loading occurred, resulting in multiple fatigue initiations in the affected area.Furthermore, there were no indications of material or manufacturing defects.Significant metal transfer onto the ceramic femoral head was observed, suggesting that disassociation of the liner and cup occurred after the liner fractured which would have compromised the locking mechanism.A manufacturing record evaluation was performed for the finished device product code: 122132148 lot number: ja1874, and no non-conformances / manufacturing irregularities were identified.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 definitive 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 functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the altrx +4 10d 32idx48od 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 complaint condition.As part of j&j medtech orthopaedics 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 code: 122132148 lot number: ja1874, and no non-conformances / manufacturing irregularities were identified.H11 additional narrative: added: d10 (concomitant).Corrected: h3.

• Brand Name: ALTRX +4 10D 32IDX48OD
• 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: 22952841
• Report Number: 1818910-2025-15106
• Device Sequence Number: 9591059
• Product Code: LPH
• UDI-Device Identifier: 10603295016151
• UDI-Public: (01)10603295016151(17)260131(10)JA1874
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K072963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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 Expiration Date: 01/31/2026
• Device Catalogue Number: 122132148
• Device Lot Number: JA1874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: +9 MM OFFSET 12/14 TAPER.; UNK HIP FEMORAL HEAD CERAMIC.; UNKNOWN HIP ACETABULAR CUP.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female