MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-106

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Osteolysis (2377); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/20/2018

Event Type  Injury  

Manufacturer Narrative

(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

Initial report: patient was revised to address loosening of the tibial component at cement to implant interface.Cement manufacturer was unknown.There was no cement bond to implant.Doi: (b)(6) 2014 dor: (b)(6) 2018 left knee.Further information received (b)(6) 2021 and reviewed: patient received a left primary attune tka to treat pain secondary to tricompartmental osteoarthritis.The patella was resurfaced and depuy smartset gentamycin cement x2 was utilized.The procedure was completed without complications.The surgeon notes that the patient has morbid obesity.Patient received a left knee revision to treat pain, impaired mobility, and osteolysis secondary to aseptic loosening.Upon entering the joint, the surgeon identified and excised periarticular synovitis.The surgeon notes there was femoral condyle and tibial metaphyseal osteolysis.The femoral component was loosened at an unknown interface and revised.The tibial tray was grossly loose and debonded at the cement to implant interface.The surgeon notes there was some femoral condyle and tibial metaphyseal bone loss.There was no reported product problem with the revised tibial insert.The patella was well-fixed and retained.The patient was revised with a depuy sigma revision construct utilizing depuy cement x 3.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2018.Left 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.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 PS FEM LT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11334745
• MDR Text Key: 232126478
• Report Number: 1818910-2021-03124
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041634
• UDI-Public: 10603295041634
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 1504-10-106
• Device Catalogue Number: 150410106
• Device Lot Number: 349107
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 6 8MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FB INSRT SZ 6 8MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR