MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-506

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

Patient Problems Edema (1820); Pain (1994); Injury (2348); Hypoesthesia (2352); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

Attune claim letter received.Claim record alleges personal injury occurred as a result of implantation of a defective depuy attune knee device.Doi: (b)(6) 2015.Dor: not reported ; unknown side.

Manufacturer Narrative

Product complaint # (b)(4).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.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 5 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9552696
• MDR Text Key: 173778438
• Report Number: 1818910-2020-00548
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049937
• UDI-Public: 10603295049937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 1516-40-506
• Device Catalogue Number: 151640506
• Device Lot Number: 471941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2014
• 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: ATTUNE MEDIAL DOME PAT 35MM; COMPETITOR CEMENT; ATTUNE MEDIAL DOME PAT 35MM; COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female