MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN TIB SLV M/L 29MM HALF POR; KNEE TIBIAL TRAY ACCESSORY

Model Number	1511-11-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	02/28/2019
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
Clinical adverse event received for pain front side target knee and limited range of motion.Event is serious and is considered moderate.Event is definitely not related to device and is probably related to procedure.Date of implantation: (b)(6) 2018, date of event (onset): (b)(6) 2019, (right knee).Treatment: oral medication and surgical knee manipulation under anesthesia intervention (no revision of products).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search did identify other reported incident(s) against the provided product/lot combination(s) since release for distribution.It was confirmed that all of the previous complaints also referenced the clinical study (b)(4) & subject i/d (b)(4).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.Corrective action was not indicated.

• Brand Name: ATUN TIB SLV M/L 29MM HALF POR
• Common Device Name: KNEE TIBIAL TRAY ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10285802
• Report Number: 1818910-2020-16114
• Device Sequence Number: 19005258
• Product Code: NJL
• UDI-Device Identifier: 10603295419624
• UDI-Public: 10603295419624
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 1511-11-101
• Device Catalogue Number: 151111101
• Device Lot Number: J0707D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 08/10/2020
• 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 CEMENTED STEM 14X50MM.; ATTUNE CEMENTED STEM 14X50MM.; ATTUNE CRS FEMORAL RT SZ 6 CEM.; ATTUNE CRS RP INSRT SZ 6 6MM.; ATUN TIB SLV M/L 29MM HALF POR.; ATUNE REV RP TIB BASE SZ 7 CEM.; COMPETITOR BONE CEMENT.; COMPETITOR BONE CEMENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Weight: 96