MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 6 10MM; KNEE TIBIAL INSERT

Model Number	1517-10-610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/20/2021
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 underwent a knee replacement on the (b)(6) 2020.She received an attune revision construct at this time.The patient had a fall a few weeks ago and ruptured her extensor mechanism.The surgeon re-operated to repair the ruptured tendon and elected to exchange the insert at the same time.Patient experience includes pain.
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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
Event or Problem Description
Additional information received indicated that there was no surgical delay and it was confirmed that the affected side was the right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CRS RP INSRT SZ 6 10MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11948015
• Report Number: 1818910-2021-11974
• Device Sequence Number: 4242970
• Product Code: NJL
• UDI-Device Identifier: 10603295056034
• UDI-Public: 10603295056034
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 05/20/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1517-10-610
• Device Catalogue Number: 151710610
• Device Lot Number: 8870000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/17/2021; 08/04/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 07/06/2021; 08/05/2021
• 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 CRS FEMORAL RT SZ 6 CEM; ATTUNE DIST FEM AUG SZ 6 12MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE POS FEM AUG SZ 6 8MM; ATTUNE POS FEM AUG SZ 6 8MM; ATUN FEM SLV M/L 40MM FULL POR; ATUN PRESSFIT STR STEM10X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE REV RP TIB BASE SZ 4 CEM; UNK ATTUNE FEMORAL; UNK ATTUNE FEMORAL
• Outcome Attributed to Adverse Event: Required Intervention