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

Model Number 1506-80-004

Device Problems Malposition of Device (2616); Unintended Movement (3026); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Local Reaction (2035); No Code Available (3191)

Event Date 09/17/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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 right primary attune to treat pain secondary to severe degenerative joint disease.The patella was resurfaced and depuy cement x 1 and competitor allograft x 1 was utilized.The procedure was completed without complications.Patient received a right tka revision to treat malalignment with tibial tray loosening and subsidence.Upon entering the joint, the surgeon and excised hypertrophic tissue in a complete capsulectomy.The tibial tray was in excessive valgus, loosened, and had subsided.The patella was well-fixed and retained.The femoral component was well-fixed but revised.There was no reported product problem with the revised tibial insert.The patient was implanted with competitor products.The procedure was completed without complications.Doi: (b)(6) 2018, doi: (b)(6) 2019, right 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 RP TIB BASE SZ 4 CEM
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10333682
• MDR Text Key: 200651660
• Report Number: 1818910-2020-17004
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295492160
• UDI-Public: 10603295492160
• 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
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-80-004
• Device Catalogue Number: 150680004
• Device Lot Number: 8826001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8MM; ATTUNE RP TIB BASE SZ 4 CEM; COMPETITOR ALLOGRAFT; SMARTSET MV 40G - EO; ATTUNE MEDIAL DOME PAT 35 MM; ATTUNE PS FEM RT SZ 5 CEM; ATTUNE PS RP INSRT SZ 5 8 MM; ATTUNE RP TIB BASE SZ 4 CEM; COMPETITOR ALLOGRAFT; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR