MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 4 POR; ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY

Catalog Number	150611004
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	06/18/2024
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 (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.
Event or Problem Description
Attune cementless 1 implantation 2022 it was reported that the attune tibia 4 showed no osteointegration and the tibia has sunk affected side: right.
Event or Problem Description
Additional information states that there was no deficiency with the attune ps rp insert sz5 5mm because they changed it to a new one and there was no surgical delay.
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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: according to the information received, "attune cementless right, 1 implantation 2022, tibia 4 no osteointegration, tibia sinks".¿the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The photograph of the explanted attune rp tib base sz 4 por revealed that the fixation surface was covered with what appears to be organic material.Review of the radiographic image shows that the tibial tray appears to be slightly tilted to the medial side of the tibia.However, the allegation of migration and loosening cannot be confirmed due to the angles at which the radiographs may have been taken and the fact that it is not possible to determine a change in the initial position of the implant based on a single radiograph.A manufacturing record evaluation was performed for the finished device [150611004 / 9898980] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.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.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.Device history lot = > a manufacturing record evaluation was performed for the finished device [150611004 / 9898980] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.Device history review = > a manufacturing record evaluation was performed for the finished device [150611004 / 9898980] number, and no non-conformances / manufacturing irregularities related to the malfunction were identified during manufacturing.

• Brand Name: ATTUNE RP TIB BASE SZ 4 POR
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 19633307
• Report Number: 1818910-2024-14228
• Device Sequence Number: 8610684
• Product Code: NJL
• UDI-Device Identifier: 10603295416265
• UDI-Public: (01)10603295416265(10)9898980
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: P830055
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2024

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: 150611004
• Device Lot Number: 9898980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 09/13/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 07/09/2024; 09/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2021
• 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 PS RP INSRT SZ5 5MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female