MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR +4 NEUT 32IDX50OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number	121932450
Medical Device Problem Codes	Fracture (1260); Noise, Audible (3273)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A year and a half ago, a doctor installed a corail-pinnacle prosthesis for a patient with a ceramic-polyethylene friction pair.Patient reported that 2 weeks ago she heard a crunch when moving the joint, and contacted the doctor.The patient underwent a revision of the hip joint due to a fracture of the liner.The doctor replaced the head.Number of patients involved - 1.The patient is in hospital, her condition is satisfactory.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary a year and a half ago, a doctor installed a corail-pinnacle prosthesis for a patient with a ceramic-polyethylene friction pair.According to her, 2 weeks ago she heard a crunch when moving the joint and contacted the doctor.On august 26, the patient underwent a revision of the hip joint due to a fracture of the liner.The doctor replaced the head.The product was not returned to depuy synthes; however, photos were provided for review.See attachment.The photo revealed that pinn mar +4 neut 32idx50od has a portion of rim fractured.Where the anti-rotation device (ard) tabs are located.Based on the quality on the photo no other defects were observed that could have contributed to the reported event.Regarding the x-ray, it is observed that the ceramic head is making direct contact with the cup, based on the findings it is reasonable to conclude that a dissociation event occurred between the liner and the cup.However, no evidence of a possible audible sound with the poly liner and another device occurred.With the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and 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.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 neut 32idx50od would contribute to the reported condition.Based on the investigation findings, the potential cause is traced to component failure, and 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 the device lot number is unknown; therefore, a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: PINN MAR +4 NEUT 32IDX50OD
• 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: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19949137
• Report Number: 1818910-2024-17121
• Device Sequence Number: 21073444
• Product Code: LPH
• UDI-Device Identifier: 10603295014324
• UDI-Public: (01)10603295014324
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K033273
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 08/09/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 121932450
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• 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: DELTA CER HEAD 12/14 32MM +5.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female