MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-00-204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Synovitis (2094); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
Patient received a primary right attune tka to treat degenerative joint disease.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right knee revision to treat pain and discomfort.Upon entering the joint, the surgeon identified adhesions as well as significant tightness of the patellar tendon extensor mechanism.The femoral component and tibial tray were revised.The patella was well-fixed and retained after the surgeon debrided peripatellar synovitis and adhesions.The surgeon performed a lateral patella tendon release with peeling to treat the extensor mechanism tightness.The patient was revised with a depuy revision tc3 construct.After removal of the primary attune products, the patient sustained a tibial condylar fracture during tibial resection.There were no additional devices used to treat the fracture, and the procedure was completed without further complications.Doi: (b)(6) 2015, dor: (b)(6) 2018, 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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FEM RT SZ 4 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11615557
• Report Number: 1818910-2021-07050
• Device Sequence Number: 3052444
• Product Code: JWH
• UDI-Device Identifier: 10603295041191
• UDI-Public: 10603295041191
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2018
• 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): 03/26/2021

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: 06/30/2025
• Device Model Number: 1504-00-204
• Device Catalogue Number: 150400204
• Device Lot Number: 677717
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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 FEM RT SZ 4 CEM; ATTUNE CR RP INSRT SZ 4 5MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; ATTUNE CR FEM RT SZ 4 CEM; ATTUNE CR RP INSRT SZ 4 5MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE RP TIB BASE SZ 4 CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR