MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-006

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Edema (1820); Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 03/19/2018

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

Der states that the patient had ltk performed on (b)(6) 2015.An attune cemented rp/ps was used.On (b)(6) 2016 the patient was revised.The poly insert was exchanged to a thicker style.On (b)(6) 2018 the patient was brought to the or for pain.The tibial tray and poly insert were exchanged.A stemmed attune tibial tray was implanted.Doi: (b)(6) 2015 for the tibial tray; (b)(6) 2016 for the insert.Dor: (b)(6) 2018, left knee.

Manufacturer Narrative

  investigation summary :no device associated with this report was received for examination.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).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Added: event, lot, expiration date, concomitant medical products, device manufacture date, (no code available (3191) is used to capture the surgical intervention and medical device removal) corrected: patient identifier.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).2018, the patient underwent a left knee revision due to pain, swelling, arthrofibrosis.The surgeon reported the tibial component was grossly loose.He noted the patellar and femoral components were well fixed.The surgeon indicated there was some loosening on the anterior aspect of the tibia component at the tibial bone interface, and so was revised.He reported significant arthrofibrosis present in the joint which was removed.The surgeon reported no intraoperative complications.The patient was implanted with attune tibial revision set, and competitor bone cement.(based on (b)(4).Additional information ad (b)(6).2019).

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 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7428793
• MDR Text Key: 105400839
• Report Number: 1818910-2018-57346
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: 10603295042600
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/19/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 1506-10-006
• Device Catalogue Number: 150610006
• Device Lot Number: 8089871
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 03/19/2018; 05/24/2018; 11/26/2019; 06/22/2020
• Supplement Dates FDA Received: 04/13/2018; 05/25/2018; 12/18/2019; 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 6 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR