MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK ATTUNE FEMORAL; KNEE IMPLANT : FEMORAL

Catalog Number UNK ATTUNE FEMORAL

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Synovitis (2094); Unspecified Musculoskeletal problem (4535)

Event Date 08/08/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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.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

Female patient received a right attune tka to treat pain and djd.The patella was resurfaced and unknown cement was utilized.The procedure was completed without complications.61-year-old female patient received a right knee revision to treat persistent pain and reduced range of motion secondary to aseptic loosening.Upon entering the joint, the surgeon debrided periarticular inflammatory tissue and sent it to pathology.The pathology report identified gross inflammation and synovitis.The patella, femoral component, and tibial tray were all loose at the cement to implant interface and revised.The surgeon identified and debrided femoral and tibial bone defects.There was no reported product problem with the revised tibial insert.The patient received an unknown revision construct.The procedure was completed without complications.Doi: (b)(6) 2015.Dor: (b)(6) 2022.Right knee.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: KNEE IMPLANT : FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16597982
• MDR Text Key: 311845430
• Report Number: 1818910-2023-06462
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female