MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINNACLE ALTRX; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	122132050
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported revision occurred due to massive metal wear during inlay dislocation and fracture following external endoprosthetic treatment.Necessary revision including cup and head replacement, as well as removal of metal wear and pseudotumor.Doi: (b)(6) 2024.Dor: (b)(6) 2026.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H11.Additional narrative: added: d9, d10 (concomitant).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 = > revision due to massive metal wear during inlay dislocation and fracture following external endoprosthetic treatment.Necessary revision including cup and head replacement, as well as removal of metal wear and pseudotumor.The product was returned to depuy synthes for evaluation.Visual analysis found that the altrx neut 32idx50od has five out of six anti-rotation device (ard) tabs sheared off.Additionally, a large portion of the rim was fractured.The fragments were not returned for evaluation.Furthermore, the implant presents signs of explantation attempts.It is evident that the edge of the liner was loaded by the femoral head, there are machining lines from the manufacturing process yet visible within the liner which would not be as obviously present had the femoral head been more centrally loaded.Based on the observations of the acetabular liner and the returned mating implants (pinn 100 w/gription 50mm and hip ball biolox 32 +5 12/14), 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 locking mechanism 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 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 neut 32idx50od 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 = > 1) quantity manufactured: 40 2) date of manufacture: 10/05/2023 3) any anomalies or deviations identified in dhr: none 4) expiry date: (b)(6)2028 5) ifu reference: ifu-0902-00-701 device history review = > a manufacturing record evaluation was performed for the finished device lot number m46r30, and no non-conformances / manufacturing irregularities were identified.Added: d1, h4 corrected: h3.

• 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 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: 24460268
• Report Number: 1818910-2026-03800
• Device Sequence Number: 21158224
• Product Code: LPH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102423
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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 Catalogue Number: 122132050
• Device Lot Number: M46R30
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 03/02/2026; 05/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 03/04/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: APEX HOLE ELIM POSITIVE STOP; HIP BALL BIOLOX 32 +5 12/14; HIP BALL BIOLOX 32 +5 12/14; PINN 100 W/GRIPTION 60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown