MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ8 5MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-805

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

Patient Problems Inflammation (1932); Pain (1994); Synovitis (2094); No Code Available (3191)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

(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 pain.It was also reported that surgeon believes there were signs of loose tibial base plate.Tibial did remove clean of cement but took several minutes to lift from the bone during retrieval.Doi: (b)(6) 2015, dor: (b)(6) 2018, left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Device history lot: null.Device history batch: null.Device history review: null.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.H6 (patient codes; no code available (3191) is used to capture the surgical intervention and medical device removal).Corrected: a1.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient underwent a left knee revision due to loosening of an unknown product at the cement to implant interface.The revision operative note findings section indicated loosening at the cement to implant interface, however, there is no mention of loosening within the note.The patella component was not revised.The surgeon noted synovitis and inflammation.Competitor cement was used during the primary operation.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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: 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.

• Brand Name: ATTUNE PS RP INSRT SZ8 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg riangaskiddy co.; cork ; EI
• MDR Report Key: 7702147
• MDR Text Key: 114413975
• Report Number: 1818910-2018-64752
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052845
• UDI-Public: 10603295052845
• 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
• Report Date: 10/08/2019

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: 12/31/2019
• Device Model Number: 1516-50-805
• Device Catalogue Number: 151650805
• Device Lot Number: 8050462
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/19/2018
• Supplement Dates Manufacturer Received: 08/10/2018; 10/08/2019; 03/05/2020
• Supplement Dates FDA Received: 08/13/2018; 10/22/2019; 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; COMPETITOR BONE CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR