MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640506
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2024
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent a tka with the insert for knee.The surgery was completed successfully without any surgical delay.On (b)(6) 2024, the surgeon informed that the insert might have been dislocated.The patient twisted the knee while trying to stand up from a squatting position.On (b)(6) 2024, the insert was replaced.
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: it was reported that on (b)(6) 2024, the patient underwent a tka with the insert for knee.The surgery was completed successfully without any surgical delay.On (b)(6) 2024, the surgeon informed that the insert might have been dislocated.The patient twisted the knee while trying to stand up from a squatting position.On (b)(6) 2024, the insert was replaced.Although the insert in question was fb type, it was dislodged.The surgeon demands an investigation for the cause of dislocation.The surgeon commented if there was an impact that dislodged the insert, it would be expected to be large enough to cause fractures.However, the patient did not do significant movement.No further information is available.The product was returned to j&j medtech orthopaedics for evaluation.Visual analysis of the returned device revealed that the attune ps fb insrt sz 5 6mm had the locking tab deformed.One groove was found fractured with the fragment still attached to the device.The other groove was found deformed.Additionally, displays marks on the surface which are typical for an insert that has been implanted.It is reasonable to conclude that the observed damage of the device caused a disassociation between the insert and tibial tray.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the attune ps fb insrt sz 5 6mm may have been caused by the reported event.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 (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.A manufacturing record evaluation was performed for the finished device [151640506 / m21a59] and no non-conformances or manufacturing irregularities were identified.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps fb insrt sz 5 6mm 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 [151640506 / m21a59] and no non-conformances or manufacturing irregularities were identified.H11 additional narrative: corrected: h3.

• Brand Name: ATTUNE PS FB INSRT SZ 5 6MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20864636
• Report Number: 1818910-2024-24989
• Device Sequence Number: 8622629
• Product Code: JWH
• UDI-Device Identifier: 10603295049937
• UDI-Public: (01)10603295049937(17)280131(10)M21A59
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111433
• 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

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: 151640506
• Device Lot Number: M21A59
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2024
• Supplement Date Received by Manufacturer: 12/26/2024; 02/13/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 12/27/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: UNKNOWN KNEE TIBIAL TRAY
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown