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

Catalog Number 150621003

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 02/29/2024

Event Type  Injury  

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 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.

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 Description

Additional information received states that there was no surgical delay.

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.

• Brand Name: ATTUNE FB TIB BASE SZ 3 POR
• Type of Device: 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
• MDR Text Key: 337102968
• Report Number: 1818910-2024-05307
• Device Sequence Number: 1
• Product Code: MBH
• UDI-Device Identifier: 10603295507406
• UDI-Public: 10603295507406
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K213781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150621003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG