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

Catalog Number	121928144
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2026
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 report, a follow-up report will be filed as appropriate.H11 additional narrative: h3, h6: a manufacturing record evaluation was performed for the finished device [product code.121928144/ lot.J41k61] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Review of the photographic evidence revealed the pinn mar +4 10d 28idx44od rim fractured near the product information.Scratches with the black filling were noted in the concave surface.Additionally, what appears to be black organic matter was observed.Overall, the device displays a worn condition.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, patient changes over time and the extraction process.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.The product was returned to depuy synthes for evaluation.Visual inspection of the pinn mar +4 10d 28idx44od revealed the rim fractured near the product information and in the back section, five out of six anti-rotation device (ard) tabs were missing likely to the fracture condition displayed.Scratches in both surfaces of the device were noted, but the ones of the concave surface were the only ones with the black filling of what appears to be organic matter.Overall, the device displays a worn condition.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, patient changes over time and the extraction process.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 dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.A manufacturing record evaluation was performed for the finished device [product code.121928144/ lot.J41k61] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The overall complaint was confirmed as the observed condition of the pinn mar +4 10d 28idx44od would contribute 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.
Event or Problem Description
It was reported that the patient underwent removal surgery.

• Brand Name: PINNACLE
• 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: 25580185
• Report Number: 1818910-2026-10620
• Device Sequence Number: 18460984
• Product Code: LPH
• UDI-Device Identifier: 10603295013433
• UDI-Public: (01)10603295013433(17)240501(10)J41K61
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K231873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• 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 Expiration Date: 05/01/2024
• Device Catalogue Number: 121928144
• Device Lot Number: J41K61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown