MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 6MM ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-506

Device Problem Naturally Worn (2988)

Patient Problems Cyst(s) (1800); Granuloma (1876); Pain (1994); Synovitis (2094); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

(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 Description

On (b)(6) 2014, the patient had a left total knee arthroplasty to address degenerative arthritis, varus deformity and flexion contracture of the left knee. Depuy components, including depuy patella, and unknown cement were used during this procedure. On (b)(6) 2016, the patient had a revision left total knee, complete and totally synovectomy, excision of reactive bone cyst to address loosening of the tibial component, polyethylene and polymethylmethacrylate wear debris disease, reactive synovitis of left knee secondary to polyethylene wear debris and cement wear debris disease, cystic formation, and knee pain. During the procedure the surgeon observed necrotic looking granulation tissue, and some bone erosions. The tibial screw was noted to be grossly loose, the tibial tray had completely debonded from the cement and the cement was noted to have degraded. There was a large reactive cyst in the medial femoral condyle that was debrided. The tibial tray, tibial insert, and femoral component were revised. The surgeon also reported that the patient¿s components had subsided, but did not specify which components. Depuy components were implanted during this procedure, including depuy cement x2. Doi: (b)(6) 2014, dor: (b)(6) 2016, (left knee).

• Brand Name: ATTUNE PS FB INSRT SZ 5 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581 ; 6107428552
• MDR Report Key: 11658958
• Report Number: 1818910-2021-07829
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295049937
• UDI-Public: 10603295049937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2019
• Device Model Number: 1516-40-506
• Device Catalogue Number: 151640506
• Device Lot Number: 546564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 57 YR
• Patient Outcome(s): Required Intervention