MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 7 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/14/2020
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
Patient was revised due to instability.Poly thickness was increased.Nothing further to report.Doi: unknown, dor: (b)(6) 2020, 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: corrected: g2 (physical manufacturer).

• Brand Name: ATTUNE PS RP INSRT SZ 7 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10315874
• Report Number: 1818910-2020-16731
• Device Sequence Number: 2234940
• Product Code: NJL
• UDI-Device Identifier: 10603295052753
• UDI-Public: 10603295052753
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2020

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
• Operator of Device: Health Professional
• Device Model Number: 1516-50-712
• Device Catalogue Number: 151650712
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/31/2020
• 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 PS RP INSRT SZ 7 12MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR