MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ5 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-507
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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 dr.X explanted crfb 5x7mm poly from the patient due to wear on the medial side.He replaced this poly after a thorough washout and increased size to cr fb 5x12mm.Doi: unknown, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ATTUNE CR FB INSRT SZ5 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12582925
• Report Number: 1818910-2021-22079
• Device Sequence Number: 3375915
• Product Code: JWH
• UDI-Device Identifier: 10603295045663
• UDI-Public: 10603295045663
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 1516-20-507
• Device Catalogue Number: 151620507
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/26/2021
• 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 CR FB INSRT SZ5 7MM; ATTUNE CR FB INSRT SZ5 7MM
• Outcome Attributed to Adverse Event: Required Intervention