MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FEM LT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Catalog Number 150410106

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Not Applicable (3189)

Event Date 08/18/2014

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

Subject id: (b)(6).Clinical adverse event received for ripping/tearing pain in left knee.Event is not serious and is considered moderate.Event is possibly related to device and definitely related to procedure.Doi: (b)(6) 2014 / doe: (b)(6) 2014.(left knee).Clinical adverse event received for persistent knee pain - global laxity.Event is serious and is considered severe.Event is possibly related to device and definitely related to procedure.Doi: (b)(6) 2014 / doe: (b)(6) 2014 / dor: (b)(6) 2015.(left knee).Revision of tibial component, femoral component and insert has occurred.

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.This does not meet a complaint definition, the electronic complaint record will be voided.Product complaint # (b)(4).Investigation summary
=
> please verify electronic complaint records (b)(4).; if these are duplicates.Please review both records to verify that the part number, lot number, patient name, and allegation are identical.If all are identical, the duplicated electronic complaint record will be voided.

• Brand Name: ATTUNE PS FEM LT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM ¿ 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 7493874
• MDR Text Key: 107573415
• Report Number: 1818910-2018-59079
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041634
• UDI-Public: 10603295041634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150410106
• Device Lot Number: 322502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• Date Device Manufactured: 12/28/2012
• 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: 63 YR
• Patient Weight: 97