MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 37MM HALF POR; KNEE TIBIAL TRAY ACCESSORY

Model Number	1511-11-102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6).Study: (b)(6).Clinical adverse event received for revision of the left knee to address infection event is serious and is considered severe event is possibly related to device and is possibly related to procedure.Date of implantation: (b)(6) 2019, date of revision #1: (b)(6) 2021 (insert), date of revision #2: (b)(6) 2021, (left knee).Treatment: irrigation & debridement, with explantation of all products.
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.
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.
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: dhr review was performed for product and lot combination 151111102/j1329t.1) quantity manufactured: (b)(4).2) date of manufacture: nov 2, 2018.3) any anomalies or deviations identified in dhr: no deviations or anomalies identified.4) expiry date: oct 31, 2028.5) ifu reference: (b)(4).

• Brand Name: ATUN TIB SLV M/L 37MM HALF POR
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12950352
• Report Number: 1818910-2021-27300
• Device Sequence Number: 20070685
• Product Code: NJL
• UDI-Device Identifier: 10603295419631
• UDI-Public: 10603295419631
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P830056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2021

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: 1511-11-102
• Device Catalogue Number: 151111102
• Device Lot Number: J1329T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 12/10/2021; 02/01/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/10/2021; 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE CR FEM LT SZ 7 CEM; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 5 CEM; SMARTSET GHV GENTAMICIN 20G; SMARTSET GHV GENTAMICIN 40G; UNK ATTUNE KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 85 KG