MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151620706

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

Patient Problem Unspecified Infection (1930)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: attune fb tib base sz 6 cem knee tibial tray component; attune cr fem rt sz 7 cem knee femur component; attune cr fb insrt sz 7 6mm knee tibial insert component; attune medial dome pat 38mm knee patella component; unknown bone cement.

Event Description

It was reported that the patient's knee was revised due to infection.During this procedure, which is the first stage of what is planned to be a two stage procedure, the prior attune primary implants were removed and replaced by a temporary antibiotic impregnated articulating spacer.Once the infection has cleared, the temporary spacer will be removed and replaced by revision knee components.No loosening and no surgical delay.Doi: (b)(6) 2018.Dor: (b)(6) 2018.Right knee.

Manufacturer Narrative

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

• Brand Name: ATTUNE CR FB INSRT SZ 7 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7897263
• MDR Text Key: 120970837
• Report Number: 1818910-2018-69993
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295045892
• UDI-Public: 10603295045892
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151620706
• Device Lot Number: HT7414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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: 55 YR