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

Catalog Number	121932148
Medical Device Problem Codes	Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an abnormal pinnacle acetabular insert failure.The wear of polyethylene and the rupture of the insert are inexplicable, the implant was correctly positioned, the patient had perfectly recovered its function and suddenly began to complain of mechanical symptoms after a few years.
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 j&j medtech, or its employees that the report constitutes an admission that the product, j&j medtech, 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: pinnacle acetabular insert failure abnormal.The wear of polyethylene and the rupture of the insert are inexplicable, the implant was correctly positioned, the patient had perfectly recovered its function and suddenly began to complain of mechanical symptoms after a few years.The product was not returned to j&j medtech orthopaedics; however, photos were provided for review.See attachment depuy25-18 picture.The photo investigation revealed that the pinn mar +4 10d 32idx48od has a large portion of the rim that is fractured and shows slight signs of wear at the edge.With the information provided is not possible to determine a specific potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables, anatomical considerations and patient changes over time, including the possibility that the damaged observed may had been caused in the extraction process.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device product description: pinn mar +4 10d 32idx48od product code: 121932148 lot number: j3899y and no non-conformances or manufacturing irregularities were identified.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 pinn mar +4 10d 32idx48od 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 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 description: pinn mar +4 10d 32idx48od product code: 121932148 lot number: j3899y and no non-conformances or manufacturing irregularities were identified.Device history review: a manufacturing record evaluation was performed for the finished device product description: pinn mar +4 10d 32idx48od product code: 121932148 lot number: j3899y and no non-conformances or manufacturing irregularities were identified.

• Brand Name: PINN MAR +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: 21979283
• Report Number: 1818910-2025-07258
• Device Sequence Number: 21106131
• Product Code: LPH
• UDI-Device Identifier: 10603295014034
• UDI-Public: (01)10603295014034(17)240430(10)J3899Y
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 04/30/2024
• Device Catalogue Number: 121932148
• Device Lot Number: J3899Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2019
• 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