MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 5 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-510
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Joint Laxity (4526); Swelling/ Edema (4577)
Date of Event	12/30/2020
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.
Event or Problem Description
Clinical notification received for revision of left total knee to address instability, with ankylosis and arthrofibrosis patient received a left knee revision and lysis of adhesions to treat pain, instability, decrease in joint flexion to 95 degrees, ankylosis, and adhesions.Upon entering the joint, periarticular effusion was evacuated.Extensive distal femoral and patellar tendon adhesions were excised which increased joint flexion to 130 degrees.The insert was revised to treat the medial lateral and anterior joint laxity.The femoral component, tibial tray, and patella were well-fixed and retained.There was no reported product problem with the revised tibial insert.The patient was revised with a depuy insert.The procedure was completed without complications.Doi: (b)(6) 2019, dor: (b)(6) 2020, left 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 CR FB INSRT SZ 5 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11272591
• Report Number: 1818910-2021-02338
• Device Sequence Number: 3347410
• Product Code: JWH
• UDI-Device Identifier: 10603295045687
• UDI-Public: 10603295045687
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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 Model Number: 1516-20-510
• Device Catalogue Number: 151620510
• Device Lot Number: HX5840
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/20/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 03/05/2021
• 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 5 10MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE CR FB INSRT SZ 5 10MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 111