MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Attune claim letter received.Claim letter alleged that patient sustained personal injury as a result of implantation of a defective depuy attune knee device.Doi: (b)(6) 2015, dor: not reported unknown 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.

• Brand Name: ATTUNE PS RP INSRT SZ 5 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9426187
• Report Number: 1818910-2019-121397
• Device Sequence Number: 19477788
• Product Code: NJL
• UDI-Device Identifier: 10603295052487
• UDI-Public: 10603295052487
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2018

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 Expiration Date: 06/30/2018
• Device Model Number: 1516-50-514
• Device Catalogue Number: 151650514
• Device Lot Number: 4014371
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 09/17/2020
• 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 FEM LT SZ 5 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR