MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-507

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

Patient Problems Pain (1994); Scar Tissue (2060); Discomfort (2330); Unspecified Tissue Injury (4559)

Event Date 09/07/2021

Event Type  Injury  

Event Description

Clinical notification received for revision to address pain.Date of implantation: (b)(6) 2020.Date of revision: (b)(6) 2021 (right knee).Treatment: revision of the tibial insert, tibial tray, femoral component, and depuy cement product.The patella component was retained.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information provided from medical record review indicates the patient received a revision due to loosening and migration of the tibial component at the implant to bone interface.It is reasonable to conclude that the device reported on this medwatch did not contribute to the reported event as the patients pain can be attributed to the tibial loosening.The tibial component was reported on report number 1818910-2022-01695.At this time depuy synthes joint reconstruction considers the device on this report to be not reportable.

• Brand Name: ATTUNE PS RP INSRT SZ 5 7MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13358503
• MDR Text Key: 284460139
• Report Number: 1818910-2022-01697
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052449
• UDI-Public: 10603295052449
• 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: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1516-50-507
• Device Catalogue Number: 151650507
• Device Lot Number: 9268833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2019
• 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 FEM POR PS RT SZ 5; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS RP INSRT SZ 5 7MM; ATTUNE RP TIB BASE SZ 5 POR; SMARTSET HV 20G
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 76 KG