MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 5 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-205

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 01/01/2021

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.

Event Description

Revision for patient experience of pain and implant loosening.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : no lot information available.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative:  added: b5, d10, h6 (medical device problem code).H6 medical device problem code was added to capture loosening in an unknown interface.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received indicated that the tibial tray and femoral components were loose.

• Brand Name: ATTUNE PS FEM RT SZ 5 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11946368
• MDR Text Key: 254489304
• Report Number: 1818910-2021-11943
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041764
• UDI-Public: 10603295041764
• 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
• Report Date: 05/17/2021

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: 1504-10-205
• Device Catalogue Number: 150410205
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/03/2021; 06/24/2021
• Supplement Dates FDA Received: 06/08/2021; 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS RP INSRT SZ 5 8MM.; ATTUNE RP TIB BASE SZ 5 CEM.
• Patient Outcome(s): Required Intervention