MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-608
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	06/19/2019
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
On (b)(6) 2015, the patient underwent a primary right knee arthroplasty to address degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.There were no indicated intra-operative complications.On (b)(6) 2019, the patient underwent a right knee revision to address pain and tibial tray loosening at the cement to implant interface.The surgeon noted excising scar tissue and some tibial bone loss.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complication's.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 at this time.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FB INSRT SZ 6 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11625225
• Report Number: 1818910-2021-07252
• Device Sequence Number: 3919936
• Product Code: JWH
• UDI-Device Identifier: 10603295045793
• UDI-Public: 10603295045793
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• 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: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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 Expiration Date: 10/31/2018
• Device Model Number: 1516-20-608
• Device Catalogue Number: 151620608
• Device Lot Number: 447814
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 05/11/2021
• 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 CR FB INSRT SZ 6 8MM; ATTUNE CR FEM RT SZ 6 CEM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 41MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR