MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151650512

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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 underwent a second left knee revision with tibial insert exchange on (b)(6) 2016 due to pain, heterotrophic ossification, patella maltracking, and an over-sized tibial insert.Doi: (b)(6) 2015; dor: (b)(6) 2016; (lt knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 5 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9292055
• MDR Text Key: 165575500
• Report Number: 1818910-2019-114840
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052470
• UDI-Public: 10603295052470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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: 10/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 151650512
• Device Lot Number: 8063908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/07/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR