MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Synovitis (2094); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/23/2020

Event Type  Injury  

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 Description

It was reported that on (b)(6) 2017, the patient received a depuy right total knee replacement, to address osteoarthritis.The knee was a cemented tibial and femoral construct, with a fixed bearing insert.The patella was also resurfaced and two batches of depuy cement were used throughout.The surgeon reported that the procedure was tolerated well without any major complications.On (b)(6) 2020, the patient's right knee was revised to address pain, aseptic loosening of the tibial baseplate at the cement to implant interface, and medial collateral ligamentous instability.It was reported that the patient had experienced pain since his primary.All infection markers were negative, while a bone scan on (b)(6) 2019 showed tibial uptake, suggesting aseptic loosening of the tibial component.The patient also demonstrated on examination, that he had a significant amount of mid flexion instability, particularly with valgus stress, indicating laxity of the medial collateral ligament.Intraoperatively, surgeon noted that there was chronic appearing synovitis.The femoral component was well fixed, while the tibial tray was not well fixed to the cement mantle.The cement mantle, on the other hand, was itself well fixed to the bone.There was insufficiency of the medial collateral ligament requiring additional constraint.The patella was well-fixed and retained.All other depuy devices were revised and a constrained competitor revision knee system implanted.Intraoperative cultures were negative for evidence of infection.Date of implantation: (b)(6) 2017, date of revision: (b)(6) 2020, (right knee).

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.

• Brand Name: ATTUNE MEDIAL ANAT PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11087941
• MDR Text Key: 224079806
• Report Number: 1818910-2020-27756
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295056645
• UDI-Public: 10603295056645
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1518-10-038
• Device Catalogue Number: 151810038
• Device Lot Number: 8498168
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ 5 8MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 5 CEM; GHV BONE CEMENT 40 GRAMS; HV BONE CEMENT 40 GRAMS; ATTUNE CR FB INSRT SZ 5 8MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 5 CEM; GHV BONE CEMENT 40 GRAMS; HV BONE CEMENT 40 GRAMS
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR