MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE FB TIB BASE SZ 3 POR; KNEE IMPLANT - TIBIAL TRAY

Catalog Number	150621003
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/29/2024
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
Subsided tibial tray was revised.Primary surgery was on (b)(6) 2023.Post op x-ray looked good.X-ray was taken when she presented to the site on (b)(6) 2023 with pain.X-ray showed subtle subsidence laterally.At her 6 week visit on (b)(6) 2023 she said she complained of pain and a crooked leg.X-rays at this time showed gross subsidence laterally and lift off medially.She was revised to a revision tibia on (b)(6) 2023.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary :according to the information received, "subsided tibial tray was revised.Primary surgery was on jan 11th.Post op x-ray looked good.X-ray was taken when she presented to the site on feb 2nd with pain.X-ray showed subtle subsidence laterally.At her 6 week visit on feb 22 she said she complained of pain and a crooked leg.X-rays at this time showed gross subsidence laterally and lift off medially.She was revised to a revision tibia on feb 29".¿the product was not returned to depuy synthes, however photos were provided for review.See attachment (img_2808.Jpeg).The x-ray investigation revealed a gap on the medial side of attune fb tib base sz 3 por.Additionally, with the angle provided by the x-rays, device seems mispositioned.However, with evidence provided, implant migration cannot be confirmed as there is no chronological information nor specific dates to verify the event.The potential cause for the reported event cannot be established.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the attune fb tib base sz 3 por would not contribute to the complained device 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 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 records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.
Event or Problem Description
Additional information received states that 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, "subsided tibial tray was revised.Primary surgery was on (b)(6).Post op x-ray looked good.X-ray was taken when she presented to the site on (b)(6) with pain.X-ray showed subtle subsidence laterally.At her 6 week visit on (b)(6) she said she complained of pain and a crooked leg.X-rays at this time showed gross subsidence laterally and lift off medially.She was revised to a revision tibia on (b)(6)".The product was not returned to depuy synthes, however photos were provided for review.The x-ray investigation revealed a gap on the medial side of attune fb tib base sz 3 por.Additionally, with the angle provided by the x-rays, device seems mispositioned.Although there is no specific dates to verify the event, it is reasonable to confirm the reported event due to the condition observed.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the attune fb tib base sz 3 por would contribute to the complained device 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 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 records evaluation (mre) was not performed as no lot number was provided for this device.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: ATTUNE FB TIB BASE SZ 3 POR
• Common Device Name: KNEE IMPLANT - TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18855924
• Report Number: 1818910-2024-05307
• Device Sequence Number: 20903524
• Product Code: MBH
• UDI-Device Identifier: 10603295507406
• UDI-Public: 10603295507406
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213781
• 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,Followup
• Report Date (Section B): 03/07/2024

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: 150621003
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 04/04/2024; 06/18/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/11/2024; 04/05/2024; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG