MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ3 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-305
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).Initial reporter 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
Medical records ad (b)(6) 2021 was reviewed.On (b)(6) 2016, the patient had a right total knee arthroplasty to address severe degenerative joint disease.Depuy components, including depuy patella, and competitor cement were used during this procedure.There were no known complications reported during the surgery.On (b)(6) 2019, the patient had a revision of the right total knee to address loosening of the tibial tray at the cement/implant and at the cement/bone interface and arthrofibrosis.Prior to surgery the patient was noted to have had stiffness and pain and has had a couple of manipulations.The patient also reported having lost range of motion.During the procedure the surgeon observed significant amount of scarring throughout the knee.The tibial tray and insert were revised.Depuy components were used during this procedure along with competitor cement.Doi: (b)(6) 2016 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 product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS RP INSRT SZ3 5MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11629307
• Report Number: 1818910-2021-07329
• Device Sequence Number: 17060564
• Product Code: NJL
• UDI-Device Identifier: 10603295052142
• UDI-Public: 10603295052142
• 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: 2016
• 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): 03/24/2021

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: 05/31/2017
• Device Model Number: 1516-50-305
• Device Catalogue Number: 151650305
• Device Lot Number: 3468838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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 MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 3 CEM; ATTUNE PS RP INSRT SZ3 5MM; ATTUNE RP TIB BASE SZ 3 CEM; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT; STRYKER SIMPLEX BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR