MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 32MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-032

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

Patient Problem Unspecified Infection (1930)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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

It was reported that on (b)(6) 2021, the patient underwent the total knee arthroplasty with the attune for the osteoarthritis of the right knee.The surgery was completed successfully without any surgical delay.After the surgery, the patient was infected.Therefore, on (b)(6) 2022, all the implants were removed.At first, the surgeon planned to remove the insert, replaced and cleansed; however, the implants were loosened.Consequently, the surgeon removed all the implants and inserted cement mold.According to the surgeon, the patient had diabetes and was not well controlled.No further information is available.Doi: (b)(6) 2021; dor: (b)(6) 2022; right knee.

Manufacturer Narrative

Product complaint # (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.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.

• Brand Name: ATTUNE MEDIAL DOME PAT 32MM
• 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: 15113099
• MDR Text Key: 296686355
• Report Number: 1818910-2022-14220
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295056676
• UDI-Public: 10603295056676
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P830055
• 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
• Report Date: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-20-032
• Device Catalogue Number: 151820032
• Device Lot Number: 9468051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2020
• 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 CRS FEMORAL RT SZ 5 CEM; ATTUNE DIST FEM AUG SZ 5 8MM; ATTUNE DIST FEM AUG SZ 5 8MM; ATTUNE POS FEM AUG SZ 5 8MM; ATUN PRESSFIT STR STEM12X110MM; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; UNK ATTUNE KNEE TIBIAL INSERT; UNKNOWN BONE CEMENT
• Patient Outcome(s): Required Intervention