MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FB INSRT SZ 5 6MM; KNEE TIBIAL INSERT

Catalog Number 151640506

Device Problem Naturally Worn (2988)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the received device was forwarded to commercialized product development for evaluation.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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 attune tibial tray was loosened, surgeon was able to extract the implanted attune tibia and pick away the cement and revise the tibia to an attune tibial revision.The femur was left in place.Loosening occurred from cement to implant interface.Cement manufacture is of competitor.After investigation, poly wear was identified on the liner.Doi: (b)(6) 2015; dor: (b)(6) 2017.Right knee.

• Brand Name: ATTUNE PS FB INSRT SZ 5 6MM
• Type of Device: 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 dr.; warsaw, IN 46582 ; 5743725905
• MDR Report Key: 7233938
• MDR Text Key: 98766293
• Report Number: 1818910-2018-52553
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049937
• UDI-Public: 10603295049937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111433
• 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
• Report Date: 01/16/2018

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: No Information
• Device Catalogue Number: 151640506
• Device Lot Number: 644448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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: 42 YR