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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/16/2021

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.

Event Description

The patient was revised to address infection.No surgical delay.Doi: (b)(6) 2021.Dor: (b)(6) 2021, right knee.

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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• 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: 12412979
• MDR Text Key: 269506775
• Report Number: 1818910-2021-19151
• 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
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 6 CEM; UNK MANUFACTURER & PRODUCT INFO; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ8 5MM; ATTUNE RP TIB BASE SZ 6 CEM; UNK MANUFACTURER & PRODUCT INFO
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR