MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 10 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-21-008
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	06/09/2021
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Clinical adverse event received for instability - ligamentous laxity.Event is serious and is considered moderate.Event is possibly related to both device and procedure.On (b)(6) 2021, the patient had a revision of the right total knee to address ligamentous laxity and pain.The tibial insert was revised.Depuy components were used during this procedure.Date of implant: (b)(6) 2020; date of event: (b)(6) 2020; date of revision: (b)(6) 2021; (right knee).Treatment: revision of insert.
Additional 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.
Event or Problem Description
Operative notes received indicated that on (b)(6) 2021, the patient had a revision of the right total knee to address ligamentous laxity and pain.The tibial insert was revised.Depuy components were used during this procedure.
Additional 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 CR FB INSRT SZ 10 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12253376
• Report Number: 1818910-2021-16619
• Device Sequence Number: 19750392
• Product Code: NJL
• UDI-Device Identifier: 10603295046271
• UDI-Public: 10603295046271
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1516-21-008
• Device Catalogue Number: 151621008
• Device Lot Number: J19W42
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 08/31/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/02/2021; 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FB INSRT SZ 10 8MM; ATTUNE CR FEM RT SZ 10 CEM; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE CR FB INSRT SZ 10 8MM; ATTUNE CR FEM RT SZ 10 CEM; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL DOME PAT 41MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 102