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); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Joint Laxity (4526); Swelling/ Edema (4577)

Event Date 02/25/2021

Event Type  Injury  

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.

Event Description

Patient received a right revision of an unknown unicompartmental knee to treat aseptic loosening.A primary attune knee was implanted.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient¿s right knee was revised to treat pain, instability, loss of function, and swelling secondary to suspected tibial tray loosening.Upon entering the joint, a large effusion was evacuated.The surgeon identified and excised extensive periarticular hypertrophic synovitis consistent with polyethylene wear.Upon inspection, the surgeon identified wear and a cold-flow deformation on the insert, with notable backside wear.The tibial tray was loosened and debonded at the cement to implant interface and revised.The surgeon notes the tibial tray had moved into varus due to an osteolytic lesion along the medial tibial plateau that the surgeon attributed to the poly debris generated by the wear from the insert.The femoral component was well fixed but revised to accommodate the revision knee devices.The patella was well-fixed with no signs of wear and retained.The patient was revised with an unknown revision knee system.The procedure was completed without complications.Doi: (b)(6) 2016, dor: (b)(6) 2021, right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

• 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: 12370816
• MDR Text Key: 268249419
• Report Number: 1818910-2021-18731
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• 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: 8307789
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 8 CEM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR