MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 4 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Synovitis (2094); Osteolysis (2377); Not Applicable (3189); No Code Available (3191)

Event Date 12/13/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reviewed medical records received (b)(6) 2018.Right knee tibia revised to address painful instability, osteolysis, and aseptic loosening of the tibial base plate.Revising surgeon identified significant synovitus, and indicated that the tibia component came out with little resistance, and that there was no bonding of the bone cement to the back side of the tibial base plate.The surgeon also noted that the cement was well bonded to the actual bone surface of the tibia.Osteolysis was identified in the proximal medial tibia.Femoral and patellar components were not revised.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Investigation summary
=
> no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy synthese considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.H10 additional narrative: added: b1, h6 (patient).H6 patient code: no code available (3191) was used to capture joint instability and surgical intervention.

• Brand Name: ATTUNE RP TIB BASE SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7572885
• MDR Text Key: 110180556
• Report Number: 1818910-2018-61421
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042587
• UDI-Public: 10603295042587
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1506-10-004
• Device Catalogue Number: 150610004
• Device Lot Number: 3612621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR