MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 5 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had a tibial fracture at time of primary implant.Was touch weight bearing to allow cementless tibia to ingrow and the fracture to heal.Patient presented for revision of tibia for subsidence.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? yes.Did the patient require revision surgery or hardware removal? yes.Was device explanted? true.Hardware/explant removal due to: tibial subsidence.Did patient require revision surgery? true.If yes, date of revision surgery.Reason for revision surgery: tibial subsidence.Doi: (b)(6) 2024.Doe: (b)(6) 2024.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : pt had a tibial fracture at time of primary implant.Was touch weight bearing to allow cementless tibia to ingrow and the fracture to heal.Patient presented for revision of tibia for subsidence.The product was not returned to depuy synthes, however photos were provided for review.See attachment [(b)(4)].The x-ray investigation revealed that the attune rp tib base sz 5 por, had indeed subsided or migrated, corroborating the reported allegation.While it's important to acknowledge that the implant itself may not be at fault, the surgical decisions and processes surrounding the implantation procedure likely played a significant role in the observed migration.This occurrence suggests a complex interplay between load-bearing requirements for proper implant fixation and the presence of a tibial fracture.Despite the necessity for load-bearing to facilitate implant stability, the fracture likely compromised the structural integrity of the bone, leading to unintended migration of the device.This underscores the importance of careful consideration of surgical techniques, patient-specific factors such as the presence of fractures, bone density and post-operative management protocols to minimize the risk of implant migration in similar cases.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint is confirmed as the observed condition of the attune rp tib base sz 5 por would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to user, 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 150611005/4131282 number, was manufactured on 16-apr-2023.18 parts were manufactured per specification and all raw materials met specification.Device history review : a manufacturing record evaluation was performed for the finished device 150611005/4131282 number, was manufactured on 16-apr-2023.18 parts were manufactured per specification and all raw materials met specification.

• Brand Name: ATTUNE RP TIB BASE SZ 5 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18978611
• Report Number: 1818910-2024-06635
• Device Sequence Number: 12404862
• Product Code: NJL
• UDI-Device Identifier: 10603295416272
• UDI-Public: 10603295416272
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• 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): 03/26/2024

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: 150611005
• Device Lot Number: 4131282
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 06/13/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 04/18/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• 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: ATTUNE CR RP INSRT SZ 5 6MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female