MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994); Synovitis (2094); No Code Available (3191)
Date of Event	12/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
Clinical adverse event received for instability of left knee.Event is serious and is considered moderate.Event is possibly related to device and is probably related to procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2019, (left knee).Treatment: left knee tibial insert revised on (b)(6) 2020.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Event or Problem Description
Revision operative notes (b)(6) 2020 indicate the patient received a left total knee revision of the tibial insert due to swelling, pain, derangement of collateral ligament, generalized ligamentous laxity and instability.Upon entering the knee, the surgeon encountered a mild effusion and mild chronic synovitis.The tibial and femoral components were well fixed and left implanted.The surgery was completed without indication of complication by the surgeon.
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.Additional narrative: patient code: no code available (3191) was used to capture joint injury.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 7 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10301487
• Report Number: 1818910-2020-16344
• Device Sequence Number: 515595
• Product Code: JWH
• UDI-Device Identifier: 10603295045915
• UDI-Public: 10603295045915
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2020

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: 1516-20-708
• Device Catalogue Number: 151620708
• Device Lot Number: J29N35
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020; 08/21/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 07/27/2020; 08/24/2020
• 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 7 CEM; ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE MEDIAL DOME PAT 41MM
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 82