MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL INSERT

Catalog Number UNK ATTUNE KNEE TIBIAL INSERT

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

Patient Problem Pain (1994)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Summary report received for attune cementless posterior stabilized rotating platform knee.Tka were completed between august 1, 2019 to december 31, 2019.60 patients were involved in the final summary.Of those 60 patients, 53 had underwent a patella resurfacing.5 revisions identified tibial revision due to loosening of the tibial component at the bone to implant interface.Tibial revision due to loosening of the tibial component at the bone to implant interface.Tibial and femoral component revision due to loosening at the bone to implant interface.Tibial and femoral component revision due to pain.Revision due to mechanical complication.Adverse events: post-hemorrhagic/anemia (21 patients) abnormal reaction/complication related to implant/surgery (8 patients) pain (6 patients) knee instability (2 patients) infection/inflammation (1 patient) osteonecrosis of tibia (1 patient) knee internal derangement (1 patient) abnormal gait (1 patient).

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot l a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK ATTUNE KNEE TIBIAL INSERT
• Type of Device: UNK ATTUNE KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13873392
• MDR Text Key: 288827031
• Report Number: 1818910-2022-05270
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL INSERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• 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 FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL TRAY; UNKNOWN KNEE IMPLANT
• Patient Outcome(s): Required Intervention