MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 38MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number 1518-20-038

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994); Osteolysis (2377); No Code Available (3191)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Patient was revised to address tibial loosening at the cement to implant interface.Cement manufacturer from competitor.It was also stated that the tibia and insert were removed, an attune revision tibia and stem were placed.The old attune tibia came out clean and was being retained by a lawyer.Doi: (b)(6) 2015.Dor: (b)(6) 2018.Left side.

Manufacturer Narrative

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.Product complaint # (b)(4).Investigation summary: complaint re-opened.This patella product was added from received additional information.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.

Event Description

Patient received a total left tka revision to treat persistent pain.The femoral component and tibial tray were loose and completely debonded at the cement to implant interface.The surgeon notes that the soft tissue surrounding the tibial cement mantle was necrotic and needed extensive debridement.The patella was well-fixed but revised.There was no reported product problem with the explanted tibial insert.The patient was revised with competitor products.The procedure was completed without complications.Doi: (b)(6) 2015, dor:(b)(6) 2018, left knee.

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.  h6 patient code: no code available (3191) used to capture surgical intervention patient code.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE MEDIAL DOME PAT 38MM
• Type of Device: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8910334
• MDR Text Key: 155046421
• Report Number: 1818910-2019-101649
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295056690
• UDI-Public: 10603295056690
• Combination Product (y/n): N
• PMA/PMN Number: K103756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 1518-20-038
• Device Catalogue Number: 151820038
• Device Lot Number: 8185346
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/20/2019
• Supplement Dates Manufacturer Received: 03/23/2020; 05/14/2020
• Supplement Dates FDA Received: 04/07/2020; 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM LT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 8 CEM; COMPETITOR BONE CEMENT; COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR