MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 6 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number 1506-10-006

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Not Applicable (3189); No Code Available (3191)

Event Date 08/06/2018

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.Concomitant medical products: unknown knee femur component; attune rp tib base sz 6 cem tibial tray; unknown bone cement; attune ps rp insrt sz 6 10mm tibial insert; unknown knee patella component.

Event Description

The patient was revised to address tibial pain as a result of loosening of the tibial component at the cement to implant interface.Cement manufacturer used was unknown.Tray had zero cement on it.Doi: (b)(6) 2015; dor: (b)(6) 2018; left knee.

Manufacturer Narrative

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.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) 2018, the patient underwent a left knee revision due to pain and tibial tray loosening at the cement to implant interface and bone to cement interface.The surgeon noted the tibial component was freed from its attachment to the cement easily and was removed.The cement was noted to have debonded from the bone itself over the entire upper surface of the tibia.Two depuy cement products were used during the primary operation.It is also noted the implantation of depuy products on (b)(6) 2015 was a revision of a unicompartmental knee replacement.However, the manufacturer of the products removed is unknown.

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. patient code: no code available (3191) used to capture the surgical intervention.

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.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.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 RP TIB BASE SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7836735
• MDR Text Key: 118881277
• Report Number: 1818910-2018-68210
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295042600
• UDI-Public: 10603295042600
• 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: 07/24/2019

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 Model Number: 1506-10-006
• Device Catalogue Number: 150610006
• Device Lot Number: 8006063
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 09/14/2018; 07/24/2019; 02/21/2020
• Supplement Dates FDA Received: 09/17/2018; 07/26/2019; 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR