MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 3 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Unspecified Infection (1930); Pain (1994); No Code Available (3191)
Date of Event	05/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Occupation: lawyer.(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
On (b)(6) 2016: patient underwent a left knee replacement due to osteoarthritis.Attune primary implants were implanted with depuy cement.No intra-operative complications noted.Patient presented with pain, swelling, and instability.Radiographs revealed failure of the tibial component with significant loosening, loss of alignment, and bone loss.Revision surgery was recommended, but the patient required significant optimization to minimize her risk profile.During that time her weight bearing was protected in a brace, although there were issues with non-compliance.She also experienced a gi bleed which required blood transfusion and further treatment.She ultimately fractured her medial tibial condyle warranting an urgent revision surgery.It should be noted the patient was diagnosed with a uti prior to the operation and was provided treatment to minimize her infection risk.On (b)(6) 2019: patient underwent a left knee revision.Findings during the surgery were well fixed femoral component, grossly loose tibial component-cement to implant interface, tibial defect with a medial and lateral condyle fracture-plate and screws placed, and well-fixed patella component (retained).Competitor products were placed with depuy cement.Doi: (b)(6) 2016, dor: (b)(6) 2019, (left knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 3 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9665084
• Report Number: 1818910-2020-03866
• Device Sequence Number: 11548821
• Product Code: JWH
• UDI-Device Identifier: 10603295045441
• UDI-Public: 10603295045441
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2020

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: 12/31/2017
• Device Model Number: 1516-20-310
• Device Catalogue Number: 151620310
• Device Lot Number: 328417
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE MEDIAL DOME PAT 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR