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

Catalog Number UNK ATTUNE KNEE PATELLA

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

Patient Problems Adhesion(s) (1695); Pain (1994); Loss of Range of Motion (2032)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Usfda mdr determination: the der noted that the surgeon remarked that arthrofibrosis likely caused the patient's symptoms, arthrofibrosis isn't distinctly a degenerative disease that would occur without the total knee being present the surgery and products can not be ruled out as contributing to the patient's pain and lack of motion.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient was revised to address lack of motion, pain and arthrofibrosis.The surgeon removed the ps rp cemented attune implant and replaced with a tc3 rp.The range of motion was much better, it was well-balanced and the patella tracked well.The components were not loose.Doi: unknown.Dor: (b)(6) 2021; right knee.

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 device history record (dhr) review, was not possible because the required lot number was not provided.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: UNK ATTUNE KNEE PATELLA
• Type of Device: ATTUNE KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11342733
• MDR Text Key: 232366182
• Report Number: 1818910-2021-03234
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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 KNEE PATELLA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5 ATTUNE FEMUR; 5 TIBIAL TRAY; 5X5 TIBIAL INSERT; PATELLA SIZE UNKNOWN; 5 ATTUNE FEMUR; 5 TIBIAL TRAY; 5X5 TIBIAL INSERT; PATELLA SIZE UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR