MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS RP INSRT SZ 8 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151650810

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

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

It was reported that upon opening the packaging on top of the foam piece that separates the poly there was a hair inside.

Manufacturer Narrative

Investigation summary; no device associated with this report was received for examination.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.Device history lot: product code 151650810, lot number 8619579.Device history review: product code 151650810, work order (b)(4) was manufactured on 26 sep 2017.(b)(4) parts were manufactured per specification and all raw materials met specification.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 8 10MM
• 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; depuy ireland 9616671; cork IN ; EI
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7956336
• MDR Text Key: 123394581
• Report Number: 1818910-2018-72166
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052883
• UDI-Public: 10603295052883
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151650810
• Device Lot Number: 8619579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 10/22/2018
• Supplement Dates FDA Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR