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

Model Number 1516-40-505

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

Patient Problems Edema (1820); Pain (1994); Swelling (2091); Synovitis (2094); No Code Available (3191)

Event Date 06/03/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Occupation is a non-healthcare professional.(b)(4).

Event Description

Patient underwent a revision secondary to pain, swelling and instability.A synovectomy was performed and poly liner was switched out.Surgeon states all components were well fixed and there were no signs of malfunction or wear on the liner.Doi: (b)(6) 2013; dor: (poly liner), (b)(6) 2015.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) is used to capture the medical device removal.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .

Event Description

Medical records received 17 june 2019 and were reviewed 01 october 2019 for mdr reportability.On (b)(6) 2013, the patient underwent total right knee arthroplasty due to degenerative joint disease.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 1.On (b)(6) 2015, the patient underwent a right knee revision due to instability, swelling, and pain.The surgeon reported mild laxity in flexion and extension.He noted extensive benign-appearing synovitis, and a synovectomy was performed.The surgeon reported no evidence of malfunction or wear to the components, and all components were well-fixed.The tibia, and femoral components were not revised.The tibial insert was revised.He noted good tracking with the patella, and it was not revised.The patient was implanted with an attune tibial insert, and there were no complications to the procedure.Doi: (b)(6) 2013; dor: (b)(6) 2015; (rt knee).

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.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.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).Investigation summary : no device associated with this report was 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.E3 initial reporter occupation: lawyer.Patient code: no code available (3191) is used to capture joint instability.

• Brand Name: ATTUNE PS FB INSRT SZ 5 5MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• MDR Report Key: 8444135
• MDR Text Key: 139571271
• Report Number: 1818910-2019-88172
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295049920
• UDI-Public: 10603295049920
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 1516-40-505
• Device Catalogue Number: 151640505
• Device Lot Number: 334874
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 5 CEM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM RT SZ 5 CEM; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR