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 Problem Pain (1994)

Event Date 03/22/2019

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 right attune knee to treat osteoarthritis.The patella was resurfaced and competitor cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain and tibial tray loosening at the cement to implant interface.The surgeon noted there was overstuffing of the patellofemoral joint with anterior placement of the femoral component as well as an asymmetrically resurfaced patella.All components were revised.The patient was revised with competitor products and cement.There is no indicated intra-operative complications.Doi: (b)(6) 2018, dor: (b)(6) 2019, right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• 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
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13168201
• MDR Text Key: 283243414
• Report Number: 1818910-2022-00181
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042587
• UDI-Public: 10603295042587
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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 Model Number: 1506-10-004
• Device Catalogue Number: 150610004
• Device Lot Number: 8634019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 32MM.; ATTUNE PS FEM RT SZ 5 CEM.; ATTUNE PS RP INSRT SZ5 5MM.; ATTUNE RP TIB BASE SZ 4 CEM.
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female