MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151650514

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Not Applicable (3189)

Event Date 05/10/2018

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

Der states that i and d with poly exchange was performed.At the two weeks post operative visit, staples were removed and the incision looked normal.The incision began to drain and the surgeon opted for i and d with poly exchange.Intra-op specimens returned positive for infection.Doi: (b)(6) 2018; dor: (b)(6) 2018; right knee.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

(b)(4)no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS RP INSRT SZ 5 14MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork ; EI
• 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: 7572789
• MDR Text Key: 110177780
• Report Number: 1818910-2018-61406
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052487
• UDI-Public: 10603295052487
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 151650514
• Device Lot Number: 8595628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2018
• Date Device Manufactured: 08/17/2017
• 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: 81 YR
• Patient Weight: 74