MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 9 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-209

Device Problems Inadequacy of Device Shape and/or Size (1583); Use of Device Problem (1670); Malposition of Device (2616); Patient-Device Incompatibility (2682)

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

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.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) 2017, the patient underwent total right knee arthroplasty due to osteoarthritis.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with depuy knee system and depuy bone cement x 1.On (b)(6) 2019, the patient underwent a right knee revision due to loosening of the tibial component, instability, oversized femoral component, and pain.The surgeon indicated significant overhang of the femoral component laterally and medially.He noted separation between the tibial component and the cement mantle.The surgeon indicated the patella was well fixed and well positioned and was retained.Patient was implanted with attune revision system and smartset cement x 2.There were no complications reported with the procedure.Doi: (b)(6) 2017; dor: (b)(6) 2019 (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.H10 additional narrative: corrected: h6(device code).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.

• Brand Name: ATTUNE PS FEM RT SZ 9 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9571185
• MDR Text Key: 185736210
• Report Number: 1818910-2020-01360
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041801
• UDI-Public: 10603295041801
• 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
• Report Date: 12/18/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-10-209
• Device Catalogue Number: 150410209
• Device Lot Number: 8531668
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 02/11/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM.
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR