MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 8 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-208

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/04/2021

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 of right total knee components due to possible 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.

Event Description

Additional information was received indicated that the components did not appear to be loose as surgeon had to use multiple instruments and saws to remove components.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE PS FEM RT SZ 8 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11826075
• MDR Text Key: 250652370
• Report Number: 1818910-2021-10316
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295041795
• UDI-Public: 10603295041795
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1504-10-208
• Device Catalogue Number: 150410208
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE PS FEM RT SZ 8 CEM; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); ATTUNE FB TIB BASE SZ 8 CEM; ATTUNE PS FB INSRT SZ 8 5MM; ATTUNE PS FEM RT SZ 8 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR