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

Model Number 1518-10-035

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

Patient Problems Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).This device was also subject of (b)(4) and (b)(4) as the patient experienced adverse events on different days with the same device.Initial reporter occupation: lawyer.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

Attune litigation records received.Patient was revised was due to pain as a result of mechanical loosening, unknown interface.Doi: (b)(6) 2017.Dor: (b)(6) 2021.Right knee.

Manufacturer Narrative

Product complaint (b)(4).Additional information provided "the depuy patella was well-fixed and retained and osteophytes were removed from the patella." due to new information received, it is reasonable to conclude that retained patella did not provide any evidence of having caused/contributed to the reported harm(s),as the surgeon elected to not revise the retained implant(s).Depuy synthes joint reconstruction does not consider this failure to be a reportable event at this time.Further updates will only be provided if additional information is received that changes the regulatory determination.

• Brand Name: ATTUNE MEDIAL ANAT 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 15844255
• MDR Text Key: 304111098
• Report Number: 1818910-2022-23470
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056638
• UDI-Public: 10603295056638
• 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,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 1518-10-035
• Device Catalogue Number: 151810035
• Device Lot Number: 8386136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2016
• 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: SMARTSET GMV 40G US EO; UNK ATTUNE KNEE TIBIAL INSERT; UNK ATTUNE KNEE TIBIAL TRAY; UNK KNEE FEMORAL ATTUNE REVISION
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR