MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 6 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-206

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 02/02/2017

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

Right attune total knee revised to address pain and aseptic loosening of both femur and tibia components.Surgeon did not clarify which interfaces were involved with regard to the loosening of each component, just that they were loose.Depuy bone cement was used in primary.Femur, tibial tray, and tibial insert products were revised.Patella product was not.Doi: (b)(6) 2015; dor: (b)(6) 2017; (right knee).Further information reported from patient "the bone cement didn't hold and also there is a problem with the component".

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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.H10 additional narrative:.

• Brand Name: ATTUNE CR FEM RT SZ 6 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11567373
• MDR Text Key: 242175617
• Report Number: 1818910-2021-06044
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041214
• UDI-Public: 10603295041214
• Combination Product (y/n): N
• PMA/PMN Number: P830055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1504-00-206
• Device Catalogue Number: 150400206
• Device Lot Number: 8107645
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE MEDIAL DOME PAT 35MM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR