MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK ATTUNE KNEE TIBIAL TRAY

Catalog Number UNK ATTUNE KNEE TIBIAL TRAY

Device Problem Loss of or Failure to Bond (1068)

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

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

On (b)(6) 2013, the patient underwent total right knee arthroplasty degenerative joint disease.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with depuy knee system and depuy bone cement x 2.On (b)(6) 2018, the patient underwent a right knee revision due to loosening of the tibial component, and pain.The surgeon reported the tibial component was not fixated to the cement mantle and was easily removed and grossly loose.He noted the femoral component was found to be stable, though was revised.The surgeon noted good patellar tracking and the patella was not revised.The patient was implanted with attune knee system and depuy cement x 2.There were no complications reported with the procedure.Doi: (b)(6) 2013.Dor: (b)(6) 2018 (rt knee).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with this report was not received for examination.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK ATTUNE KNEE TIBIAL TRAY
• Type of Device: KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, PA 19380-0988 ; 6103142063
• MDR Report Key: 9327824
• MDR Text Key: 166537018
• Report Number: 1818910-2019-116386
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ATTUNE KNEE TIBIAL TRAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNK ATTUNE FEMORAL; UNK ATTUNE KNEE PATELLA; UNK ATTUNE KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR