MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE PS FB INSRT SZ 8 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640806

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

Patient Problem No Code Available (3191)

Event Date 09/12/2017

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.Device was used for treatment, not diagnosis.(b)(4).

Event Description

Patient underwent a left attune tka utilizing depuy cement on (b)(6) 2013.She was revised on (b)(6) 2017 for aseptic loosening of the tibial and femoral component utilizing a competitor¿s system.Surgeon notes significant inflammatory response synovitis requiring removal.Patellar component was not revised.Surgeon notes the femoral component was slightly loose and tibial component was frankly loose.Loosening interface was not provided.Doi: (b)(6) 2013; dor: (b)(6) 2017.

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

Manufacturer Narrative

This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: ATTUNE PS FB INSRT SZ 8 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8444304
• MDR Text Key: 139576147
• Report Number: 1818910-2019-88184
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050353
• UDI-Public: 10603295050353
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 151640806
• Device Lot Number: 412324
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR