MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-10-032

Device Problem Naturally Worn (2988)

Patient Problems Adhesion(s) (1695); Pain (1994); Synovitis (2094); Not Applicable (3189); No Code Available (3191)

Event Date 03/23/2018

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

Received medical records on (b)(6) 2018.Records indicated that right attune knee was revised to address mechanical loosening of the tibial component.Revising surgeon identified a large effusion, and "marked, extensive synovitis secondary to polyethylene wear based on its appearance".He indicated that the tibia component was grossly loose, removed without the need of instruments.The femur and patella components were well-fixed, and not revised.Doi: (b)(6) 2015; dor: (b)(6) 2018; (right 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 will be filed as appropriate.

Event Description

Medical records alleges pain.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  patient code: no code available ((b)(4)) used to capture the surgical intervention.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: update 21-jan-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.E3 initial reporter occupation: lawyer.

• Brand Name: ATTUNE MEDIAL ANAT PAT 32MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7604697
• MDR Text Key: 111145342
• Report Number: 1818910-2018-62262
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056621
• UDI-Public: 10603295056621
• Combination Product (y/n): N
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 1518-10-032
• Device Catalogue Number: 151810032
• Device Lot Number: 8100813
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE PS FB INSRT SZ 5 6MM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 93