MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-035

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Pain (1994); Loss of Range of Motion (2032); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.(b)(4) - jul 05 2022.(b)(4) medical records ad 23 jun 2022 was reviewed by a clinician on 5-jul-2022.Primary operative notes of the left knee were provided that confirm doi is (b)(6) 2017.The left primary tka was performed successfully without complication.Competitor cement was utilized and the patella was resurfaced.This complaint will be updated with part/lot information, which is provided on page 31.Revision notes indicate that on 22-dec-20, the patient underwent a left knee revision.Notes indicate the patient underwent a previous left extension mechanism reconstruction in 2019.This will be captured on a linked pc.The patient continues to have pain "in the extensor lag on the lle" as well as gapping in the patient's quad area.She also continues to have extensor weakness so an extensor mechanism reconstruction using mesh was performed during the revision.Significant atrophy in the quad muscle was noted along with stretching of the last extension mechanism repair.Gray tissue noted along the tibial tray.Tray loosening was found at the implant to cement interface.Pmh includes left knee patellar tracking disorder on 8/4/2021 though no further information provided on any intervention received.This event will be captured on a linked pc as well.Operative notes involving the right knee are also included in this attachment, though (b)(4) (right knee) will be updated with this information.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 Description

Hold for lois 7/11/2022 litigation complaint received ad 1 mar 2022.Patient was revised was due to loosening of tibial tray at the cement to implant interface.There was no good attachment between the metal and cement interface.Patient also alleged pain and swelling.Doi: (b)(6) 2017, dor: (b)(6) 2020, left knee.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 14976079
• MDR Text Key: 295603477
• Report Number: 1818910-2022-12677
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1518-20-035
• Device Catalogue Number: 151820035
• Device Lot Number: 8463095
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; ATTUNE PS FB INSRT SZ 6 5MM.; ATTUNE PS FEM LT SZ 6 CEM.; STRYKER BONE CEMENT.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female