MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 ATTUNE CR FB INSRT SZ 4 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151620406

Device Problem Naturally Worn (2988)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/24/2017

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.

Event Description

Uncommon poly wear attune inlay.

Manufacturer Narrative

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

Manufacturer Narrative

Product complaint: (b)(4).Investigation summary: evaluation of the returned device confirms the reported event.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will 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 4 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INT'L LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork, munster ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7181799
• MDR Text Key: 96949454
• Report Number: 1818910-2018-50869
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295045533
• UDI-Public: 10603295045533
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2017

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: 151620406
• Device Lot Number: 460349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/16/2018; 02/22/2018; 04/04/2018
• Supplement Dates FDA Received: 01/18/2018; 03/02/2018; 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2014
• 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