MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640505

Device Problem Naturally Worn (2988)

Patient Problems Bone Fracture(s) (1870); Pain (1994)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation of the returned device identified polyethylene wear.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Patient manifests pain.Studies result in a staphylococcus aureus.Subsequent control is performed with radiographs where slackening and posterior fracture of the tibial wall is clearly visualized, for which reason it is decided to perform component removal.The patient (b)(6) was operated on total knee prosthesis on (b)(6) 2017.

• Brand Name: ATTUNE PS FB INSRT SZ 5 5MM
• Type of Device: ATTUNE IMPLANT : 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 ; 1210 ward avenue; west chester, PA 19380 ; 6107428552
• MDR Report Key: 8220289
• MDR Text Key: 132196388
• Report Number: 1818910-2019-79967
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049920
• UDI-Public: 10603295049920
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151640505
• Device Lot Number: 747859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention