MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 41MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-041

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/09/2021

Event Type  Injury  

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 Description

It was reported that they resected the infected knee.Doi: (b)(6) 2016.Dor: (b)(6) 2021; right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary 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 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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE MEDIAL DOME PAT 41MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11713628
• MDR Text Key: 247937135
• Report Number: 1818910-2021-08558
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056706
• UDI-Public: 10603295056706
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/09/2021

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
• Device Operator: Health Professional
• Device Model Number: 1518-20-041
• Device Catalogue Number: 151820041
• Device Lot Number: 8290942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE PS FB INSRT SZ 9 5MM; ATTUNE PS FEM RT SZ 9 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR