MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT; KNEE INSERT

Catalog Number UNK ATTUNE KNEE TIBIAL INSERT

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

Patient Problems Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical adverse event received for septic knee: infection - deep.Event is serious and is considered severe.Event is definitely related to device and is possibly related to procedure.Date of event (onset): (b)(6) 2020.(right knee).Treatment: revision surgery.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history review : product/lot information is not available.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: KNEE INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10872339
• MDR Text Key: 217301471
• Report Number: 1818910-2020-25065
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 14X30MM; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUNE CRS FB TIB BASE SZ 6 CEM; DEPUY CMW 3 40G; UNK ATTUNE KNEE TIBIAL INSERT; ATTUNE CEMENTED STEM 14X30MM; ATTUNE CR FEM RT SZ 6 NAR CEM; ATTUNE MEDIAL DOME PAT 38MM; ATUNE CRS FB TIB BASE SZ 6 CEM; DEPUY CMW 3 40G; UNK ATTUNE KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 91