MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN MAR NEUT 36IDX58OD; HIP ACETABULAR LINERS

Catalog Number	121936058
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/04/2024
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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
This is the second revision of this acetabulum, the first procedure was reported with (b)(4).The polyethylene liner became dissociated from the pinnacle sector cup in that instance, and the same has happened here.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the catalog/model number was not provided, the (01)gtin is 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: this is the second revision of this acetabulum; the first procedure was reported with (b)(4).The polyethylene liner became dissociated from the pinnacle sector cup in that instance, and the same has happened here.There is thought that there may be something wrong with the interface between the liner and the cup.I have requested that the liner and cup be decontaminated and available to be sent for inspection.The sector cup was explanted and revised with a pinnacle multihole cup and 40mm liner.The product was returned to depuy synthes for evaluation.Visual analysis of the returned device revealed that the rim of the pinn mar neut 36idx58od has (b)(4) anti-rotation device (ard) tabs sheared off.The broken fragments were not returned for evaluation.Additionally, the liner appeared to have been edge loaded causing eccentric deformation in the rim of the device and ultimately contributing to the failure of the anti-rotation devices (ards).Based on the observations of the pinn mar neut 36idx58od and the returned femoral head, 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 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 manufacturing record evaluation was performed for the finished device [121936058/4182463] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.A dimensional inspection for the liner was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the pinn mar neut 36idx58od would have contribute to the complained device issue.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: a manufacturing record evaluation was performed for the finished device [121936058/4182463] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.Device history review: a manufacturing record evaluation was performed for the finished device [121936058/4182463] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: PINN MAR NEUT 36IDX58OD
• Common Device Name: HIP 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: 19742684
• Report Number: 1818910-2024-15178
• Device Sequence Number: 7719775
• Product Code: LPH
• UDI-Device Identifier: 10603295014478
• UDI-Public: (01)10603295014478(17)280531(10)4182463
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K010171
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 07/15/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121936058
• Device Lot Number: 4182463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/07/2024; 09/24/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/12/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2023
• 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: DLT TS CER HD 12/14 36MM +8.5.; PINN SECTOR W/GRIPTION 58MM.; UNK HIP FEMORAL HEAD CERAMIC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male