MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR RP INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-30-607
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	06/04/2020
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
The patient was revised to address pain and loose flexion.It was assumed that the tray was loose but it was very well fixed and there was less than 50% of the tray that had no cement, the rest of it had bone and cement attached to it.Doi: 2015.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.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: ATTUNE CR RP INSRT SZ 6 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10160922
• Report Number: 1818910-2020-13931
• Device Sequence Number: 2911289
• Product Code: NJL
• UDI-Device Identifier: 10603295047889
• UDI-Public: 10603295047889
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2020

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: 1516-30-607
• Device Catalogue Number: 151630607
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2020
• Supplement Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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 CR FEM LT SZ 6 CEM,; ATTUNE CR RP INSRT SZ 6 7MM,; ATTUNE PR TIBIAL TRAY OLD STYLE.; ATTUNE CR FEM LT SZ 6 CEM,; ATTUNE CR RP INSRT SZ 6 7MM,; ATTUNE PR TIBIAL TRAY OLD STYLE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR