MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 5 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-512

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2021

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 the locking mechanism on poly damage during implantation.Surgical delay of 1 minute.Ed: (b)(6) 2021.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a device history record (dhr) review was conducted by the manufacturing site.The dhr review revealed no deviations or nonconformance's were noted.

• Brand Name: ATTUNE PS FB INSRT SZ 5 12MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11252300
• MDR Text Key: 229431311
• Report Number: 1818910-2021-02103
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295049975
• UDI-Public: 10603295049975
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1516-40-512
• Device Catalogue Number: 151640512
• Device Lot Number: HM9952
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention