MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE PATELLA

Catalog Number UNK ATTUNE KNEE PATELLA

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526)

Event Date 07/12/2017

Event Type  Injury  

Event Description

Patient received a left attune knee to treat severe osteoarthritis.The patella was resurfaced and competitor cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a left knee revision to address tibial tray loosening at the cement to implant interface, tibial tray migration, instability, decreased range of motion, poly wear, synovitis, and scar tissue.The tibial tray, tibial insert, and femoral component were revised.The patella component was retained.However, a lateral facet impingement surgery and lateral patellar facetectomy were performed.Also, scar tissue was removed around the patella.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017, dor: (b)(6) 2021, left knee.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

On (b)(6) 2017, the patient had a left total knee arthroplasty to address left knee osteoarthritis.Depuy components were used during this procedure including depuy patella and competitor cement x2.On (b)(6) 2021, the patient had a left revision and lateral patellar facetectomy to address failed left total knee arthroplasty.Competitor components were used during this procedure, including competitor cement.The indications included polyethylene wear and gross loosening of the tibial component.There was settling of the varus deformity and knee instability.During the procedure, the surgeon observed substantial synovitis from polyethylene debris.There was substantial scar tissue overriding the knee and there was overgrowth of the bone.The femoral, tibial tray, and tibial insert were revised.Doi:(b)(6) 2017.Dor:(b)(6) 2021.(left knee).

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: UNK ATTUNE KNEE PATELLA
• Type of Device: KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13118068
• MDR Text Key: 282964709
• Report Number: 1818910-2021-29050
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE PATELLA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 02/02/2022; 02/15/2022
• Supplement Dates FDA Received: 02/03/2022; 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 7 5MM; ATTUNE PS FEM LT SZ 7 CEM; SIMPLEX HV CEMENT; STRYKER SIMPLEX HV CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female