MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 2 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-205
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/25/2020
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 on (b)(6) 2020, the primary surgery was performed via tka with the insert.After the surgery, it was confirmed that the spin-out occurred.On (b)(6) 2020, the revision surgery was performed replacing the insert.No further information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not 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.Device history lot : lot information not available.

• Brand Name: ATTUNE CR RP INSRT SZ 2 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11698300
• Report Number: 1818910-2021-08362
• Device Sequence Number: 3634511
• Product Code: NJL
• UDI-Device Identifier: 10603295047384
• UDI-Public: 10603295047384
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1516-30-205
• Device Catalogue Number: 151630205
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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