MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC 1818910 ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150600004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Pain (1994)

Event Date 07/18/2017

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 25 may 2018 medical records received.After review of the medical records for mdr reportability, the patient was revised to address loosening of tibial component, lysis of adhesions, and pain.Loosening occurred at the tibial tray/cement interface and depuy cement was used.(b)(6) 2015.Dor: (b)(6) 2017; right knee.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Pc-(b)(4).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.

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7613130
• MDR Text Key: 111442098
• Report Number: 1818910-2018-62510
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 150600004
• Device Lot Number: 8104397
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 07/26/2018
• Date Device Manufactured: 04/20/2015
• 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: 71 YR