MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CRS RP INSRT SZ 6 16MM; KNEE TIBIAL INSERT

Model Number	1517-10-616
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	03/13/2020
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 to address infection.The patient came in with an infected total knee.The prior implants were also a second stage of an infected knee.The implants were removed and a spacer was placed in the knee.The depuy implants performed perfectly.Doi: (b)(6) 2018.Dor: (b)(6) 2020, right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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.Per internal procedures, the event information and any investigational inputs received as part of required follow up were reviewed.For this investigation, no immediate action was required as no alleged deficiency with the device was identified.Monitor ¿ exempt per wi-7915 - known possible complication of joint replacement surgery.No device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot number combination.Based on the inability to find any additional related reports against the provided product code/lot number combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.The reported event is considered one of the possible complications of joint replacement.Investigational inputs were requested as indicated per internal procedures for this failure mode.The complaint information provided has been reviewed for complaint coding, medical device reporting, and other data required by the complaint system.Follow-up for additional event information, if applicable, was conducted utilizing work instruction wi-7915 appendix a.Without the physical complaint sample associated with this report, it was not possible to determine if the device failed to meet specifications at the time it was released for distribution.The device associated with this event was used in the treatment of the patient as prescribed by the presiding surgeon.From the event information received, it was not possible to determine the relationship of the device to the reported event.No evidence was found indicating product error was a contributing factor.The need for corrective action was not indicated.Depuy considers the investigation closed.Should additional info be received, the investigation will be re-opened as necessary.

• Brand Name: ATTUNE CRS RP INSRT SZ 6 16MM
• Common Device Name: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9906634
• Report Number: 1818910-2020-09774
• Device Sequence Number: 644000
• Product Code: NJL
• UDI-Device Identifier: 10603295056065
• UDI-Public: 10603295056065
• 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 Implanted Year: 2018
• 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): 03/13/2020

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 Expiration Date: 11/30/2022
• Device Model Number: 1517-10-616
• Device Catalogue Number: 151710616
• Device Lot Number: 8683711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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 CRS FEMORAL RT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 16MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE DIST FEM AUG SZ 6 8MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE POS FEM AUG SZ 6 4MM; ATTUNE POS FEM AUG SZ 6 8MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN PRESSFIT STR STEM12X110MM; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 45MM FULL POR; ATUNE REV RP TIB BASE SZ 6 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR