MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-124

Device Problem Noise, Audible (3273)

Patient Problems Synovitis (2094); Discomfort (2330); Unspecified Musculoskeletal problem (4535); Unspecified Tissue Injury (4559)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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) 2020, the patient underwent the total knee arthroplasty with the attune for the osteoarthritis of the left hip joint.The surgery was completed successfully without any surgical delay.After the surgery, the total knee arthroplasty for the right hip joint was to be performed.The patient complained that she did not feel pain; however, there was discomfort and unusual noise when standing up from a sitting position.In addition, patellar crepitus is suspected.On (b)(6) 2020, the patient underwent the endoscopic surgery before the total knee arthroplasty for the right hip joint.In the endoscopic surgery, synovial membrane behind the quadriceps muscle was resected and hemostatic using a shaver and a vulcan.The surgery was completed successfully without any surgical delay.According to the surgeon, this was the first time he had seen patellar crepitus, even though he has been using the attune for many years.The surgeon understands that the attune is less likely to occur patellar crepitus with this design than with previous pfcs models.The patella has been replaced with an appropriately sized implants and the patellar osteophytes have been cut with a bone saw.Additionally, the sub patellar fat body, the patellar tendon, and the synovial membrane behind the quad muscles were nicely treated in the surgery, so that the surgeon could not find the cause of this event.No further information is available.

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 PS FEM LT SZ 4 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14800467
• MDR Text Key: 295035001
• Report Number: 1818910-2022-11720
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295041696
• UDI-Public: 10603295041696
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-124
• Device Catalogue Number: 150410124
• Device Lot Number: 9448398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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 MEDIAL DOME PAT 32MM; ATTUNE PS RP INSRT SZ 4 7MM; ATTUNE RP TIB BASE SZ 4 CEM
• Patient Outcome(s): Required Intervention
• Patient Sex: Female