MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151820041

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Adhesion(s) (1695); Bone Fracture(s) (1870); Pain (1994); Fibrosis (3167)

Event Date 01/24/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint #(b)(4).E3 initial reporter occupation: lawyer.Investigation summary : no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H6: component code: appropriate term/code not available (g07002) used to capture no findings available.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

8 dec 2023 and 13 dec 2023 medical records reviewed.(b)(6) 2023 patient under went an arthoscopic excision for scar tissue due to snapping.There were small bands of scar tissue along the lateral gutter and retinaculum and some at the patella.The only depuy product in the patient was the patella which was implanted on (b)(6) 2021.Doi: 02 mar 2021 (patella).Doe: (b)(6) 2023.Right knee.

Event Description

On (b)(6) 2023, the patient had an arthroscopic scar excision of the right knee to address snapping scar tissue, fibrosis, and status post-revision right knee arthroplasty.The surgeon also ran the patient through a full range of motion while the patient was anesthetized.Medical records note the patient has pain and fibrosis due to internal orthopedic prosthetic devices.Onset was (b)(6) 2022 when the patient noticed a loud pop in the right knee when he did a deep squat.During the procedure, the surgeon reported that there were some small bands of scar tissue along the lateral gutter and retinaculum as well as some at the patella.The patella had no sign of wear or failure.No components were revised.

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 MEDIAL DOME PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18383775
• MDR Text Key: 331216706
• Report Number: 1818910-2023-25953
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056706
• UDI-Public: 10603295056706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 151820041
• Device Lot Number: 9390656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/22/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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: 52 YR
• Patient Sex: Male