MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 4 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640410
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
It was reported that the patient underwent a revision total knee arthroplasty over attune primary total knee fixed bearing due to patient dissatisfaction and pain.The surgeon removed both femoral and tibial components without issue, they were well fixed.They did take some effort to removed even formed the revision procedure and satisfied with the range motion of the patient.It did involved a patient.Left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary = > no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 4 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8500254
• Report Number: 1818910-2019-90317
• Device Sequence Number: 2515825
• Product Code: JWH
• UDI-Device Identifier: 10603295049821
• UDI-Public: 10603295049821
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2019

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 151640410
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR