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

Model Number	1516-40-708
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Osteolysis (2377)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.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
Medical records ad 30 oct 2020 was reviewed.On (b)(6) 2015, the patient had a right total knee arthroplasty.Depuy components, including patella were implanted.Competitor cement was used.There were no complications noted in the operative notes.On (b)(6) 2019, the patient had a revision right total knee arthroplasty to address aseptic loosening of tibial component at the implant/cement interface, pain, and osteolysis around the femoral component.There was no mention of revising the patella.Competitor components including competitor cement were utilized in this procedure.Doi: (b)(6) 2015 ; dor: (b)(6) 2019 (right knee).
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.Should additional information be received, the information will be reviewed and the investigation may 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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS 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: 10949990
• Report Number: 1818910-2020-26225
• Device Sequence Number: 3216510
• Product Code: JWH
• UDI-Device Identifier: 10603295050230
• UDI-Public: 10603295050230
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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: 01/31/2020
• Device Model Number: 1516-40-708
• Device Catalogue Number: 151640708
• Device Lot Number: 622552
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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 FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 7 8MM; ATTUNE PS FEM RT SZ 7 CEM; COMPETITOR (ZIMMER) BONE CEMENT; COMPETITOR (ZIMMER) BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR