MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 3 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Catalog Number 150610003

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/14/2019

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

Early failure of the tricompartmental knee attune prosthesis : the acrylic sealing of the tibial plate was ineffective.Doi: (b)(6) 2017; dor: (b)(6) 2019.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint #(b)(4).Investigation summary: no device was received.Root cause undetermined.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: dhr review product code 150610003, work order (b)(4) was manufactured on 11th december 2016.20 parts were manufactured per specification and all raw materials met specification.There were no nc¿s or deviations associated with this lot, work order (b)(4) was completed and met specification.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE RP TIB BASE SZ 3 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8830656
• MDR Text Key: 152326218
• Report Number: 1818910-2019-99305
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042570
• UDI-Public: 10603295042570
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 150610003
• Device Lot Number: 8434170
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 3 CEM; ATTUNE PS RP INSRT SZ3 5MM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 3 CEM; ATTUNE PS RP INSRT SZ3 5MM
• Patient Outcome(s): Required Intervention