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

Model Number 1506-00-004

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Edema (1820); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient received a left knee revision to treat a flexion contracture of 5 degrees.Upon entering the joint, the surgeon evacuated a small effusion and debrided periarticular synovitis.The tibial tray was grossly loose and easily removed.The surgeon excised cystic lesion from the underlying tibial bone.The femoral component was well fixed but revised.There was no reported product problem with the revised tibial insert.The patella was well fixed and retained.The patient was revised with competitor products.The procedure was completed without complications.Doi: (b)(6) 2014.Doe: (b)(6) 2014 (mua, no revision, captured in (b)(4)).Dor: (b)(6) 2020; left knee.

Manufacturer Narrative

Product complaint # (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.

• Brand Name: ATTUNE FB 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: 10785913
• MDR Text Key: 214590492
• Report Number: 1818910-2020-23919
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295042389
• UDI-Public: 10603295042389
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 1506-00-004
• Device Catalogue Number: 150600004
• Device Lot Number: 7868562
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 12/04/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ5 7MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G; ATTUNE CR FB INSRT SZ5 7MM; ATTUNE CR FEM LT SZ 5 NAR CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET GHV GENTAMICIN 40G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR