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 Problems Edema (1820); Inflammation (1932); Muscular Rigidity (1968); Pain (1994); Weakness (2145); Discomfort (2330); No Code Available (3191)

Event Date 03/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 pain and discomfort.Doi: (b)(6) 2017.Dor 1: (b)(6) 2018 (captured in (b)(4)).Dor 2: mar (unk year).

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.Added: h6 (patient).

• 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
• MDR Report Key: 10216488
• MDR Text Key: 197092333
• Report Number: 1818910-2020-14786
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; SZ 38 MEDIALIZED 3-PRONG PATELLA; SZ 5 RT PS FEMUR; SZ 5X5 PS TIBIA; UNK ATTUNE KNEE TIBIAL INSERT; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT; SZ 38 MEDIALIZED 3-PRONG PATELLA; SZ 5 RT PS FEMUR; SZ 5X5 PS TIBIA; UNK ATTUNE KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR