MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 10 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-41-005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Patient received a right attune total knee to treat advanced tricompartmental osteoarthritis of the right knee.The patella was resurfaced, and depuy cement x2 was utilized.The procedure was completed without complications.Records indicate the patient received a revision of the right knee.The indications for the revision and the components revised are unknown.There were no revision operative notes provided.Doi: (b)(6) 2016; dor: (b)(6) 2019; right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.
Additional Manufacturer Narrative
This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: ATTUNE PS FB INSRT SZ 10 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9865057
• Report Number: 1818910-2020-08806
• Device Sequence Number: 16882112
• Product Code: JWH
• UDI-Device Identifier: 10603295050629
• UDI-Public: 10603295050629
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2020

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 Expiration Date: 01/31/2018
• Device Model Number: 1516-41-005
• Device Catalogue Number: 151641005
• Device Lot Number: 326984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 04/27/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/17/2020; 04/28/2020
• 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 FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FB INSRT SZ 10 5MM; ATTUNE PS FEM RT SZ 10 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FB INSRT SZ 10 5MM; ATTUNE PS FEM RT SZ 10 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR