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

Catalog Number UNK ATTUNE FEMORAL

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Ambulation Difficulties (2544); Joint Laxity (4526); Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.E3 initial reporter occupation: lawyer.E3 initial reporter occupation: lawyer.Follow-up is being conducted to obtain legal contact information.If/when the contact information is received, a supplemental med watch report will be submitted.H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Event Description

In (b)(6) 2015, patient complaining of pain in her knees, underwent several examinations, as a result of which she was diagnosed with 'mild gonarthrosis' and 'goose foot tendinopathy' in her left knee' and was referred for arthroplasty surgery.On (b)(6) 2015, the patient underwent a planned arthroplasty operation on her left knee at the hospital in (b)(6), where she was hospitalized until (b)(6).Early on after the operation, the patient began to complain of constant pain in her left knee, instability and an inability to walk.In (b)(6) 2016, as the intense knee pain persisted, the patient was hospitalized and ruled out the presence of a periprosthetic infection.Despite the long period of time that has elapsed and the numerous therapies, examinations and tests that have been carried out, the arthroplasty operation can be considered an absolute failure and the applicant's situation has not improved, with constant and intense pain persisting in her left knee with serious functional and movement limitations and consequent inability to walk.The current situation is such that the patient has also lost her autonomy in the acts of daily living (housekeeping, personal care, travelling and going out and so on) for which she is now constantly dependent on her daughter.It was alleged that there has been mispositioning of a component as a result of which there has been lateralization of the patella.Doi: (b)(6) 2015.Dor: unknown.Affected side: left knee.

• Brand Name: UNK ATTUNE FEMORAL
• Type of Device: KNEE FEMORAL IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17610648
• MDR Text Key: 321812689
• Report Number: 1818910-2023-17397
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE FEMORAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/24/2023
• 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
• Treatment: UNK ATTUNE KNEE TIBIAL TRAY; UNK ATTUNE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Sex: Female