MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 7; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-207
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: 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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision completed due to loosening of the femoral component at the bone to cement interface.It was also reported that the patient has a right total press fit attune knee.The patient has start up pain.All other options were tried.The surgeon believes that the femoral component is loose.The femur was revised.It was very difficult to remove the femur.After removal, it is noticed that the femur just had fibrous growth.The surgeon was able to peel the tissue off the backside of the femoral component.The tibial tray was well fixed and retained.Doi: (b)(6) 2021.Dor: (b)(6) 2022.Affected side: right knee.Additional information: us-fda mdr reportability determination: a knee was revised to address implant loosening of the porous coated femur component.Although the complaint description stated loosening occurred at the bone to cement interface, this is clearly in error, as the remainder of the report indicates that it is a porous coated femur (not cemented) and that the femur had only fibrous ingrowth, with tissue being able to be peeled directly off of the back of the femur implant.Given this, we can exclude bone cement from the report, and focus on the femur.No other knee implant plays any role in the osseointegration of a porous coated femoral implant and its interface with the femur bone except the femur component itself.This is a function of the femoral implant porous coating.It is therefore reasonable to conclude that no other implant, retained or revised, caused or contributed to the implant loosening of the femur.

• Brand Name: ATTUNE FEM POR PS RT SZ 7
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15469788
• Report Number: 1818910-2022-18540
• Device Sequence Number: 11832613
• Product Code: MBH
• UDI-Device Identifier: 10603295042068
• UDI-Public: 10603295042068
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1504-11-207
• Device Catalogue Number: 150411207
• Device Lot Number: 9574094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE PS RP INSRT SZ 7 10MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male