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

Model Number 1518-10-035

Device Problems Failure To Adhere Or Bond (1031); Naturally Worn (2988)

Patient Problems Muscular Rigidity (1968); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/25/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On 20 apr 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised (b)(6) 2017 to address left knee aseptic failure.During the surgery notes, the surgeon reported that there was debonding of the cement to the tibial component, patella polywear, and stiffness.Competitor components were placed during the revision.Doi: (b)(6) 2017; dor: (b)(6) 2017; (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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: h6 patient code: no code available (3191) was used to capture medical device removal and surgical intervention.

• Brand Name: ATTUNE MEDIAL ANAT PAT 35MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7526856
• MDR Text Key: 108674308
• Report Number: 1818910-2018-60006
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295056638
• UDI-Public: 10603295056638
• 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,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 1518-10-035
• Device Catalogue Number: 151810035
• Device Lot Number: 3625614
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR