MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 35MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number 151820035

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

Patient Problems Adhesion(s) (1695); Pain (1994); No Code Available (3191)

Event Date 05/21/2019

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.No device associated with this report was 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.

Event Description

It was reported that the patient informed surgeon that she is seeking litigation.Unknown reason for revision and no obvious loosening.Doi: (b)(6) 2017; dor: (b)(6) 2019; left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device associated with this report was 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, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE MEDIAL DOME PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• 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: 9358070
• MDR Text Key: 185007254
• Report Number: 1818910-2019-117505
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056683
• UDI-Public: 10603295056683
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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: 01/31/2022
• Device Catalogue Number: 151820035
• Device Lot Number: 8467036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2017
• 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: 56 YR