MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-50-706

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 05/12/2021

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

Patient was revised due to infetion and loosening of the unknown component at the bone to cement interface.Competitor cement was used.Patient had a left tka (b)(6) 2020 and explanted left tka on (b)(6) 2021.41 patella, 7 left ps femur, 7/6 mm rp attune poly and 8 attune rp tray.Doi: (b)(6) 2020 dor:(b)(6), 2021 left 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 : 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.

• Brand Name: ATTUNE PS RP INSRT SZ7 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11877646
• MDR Text Key: 252438261
• Report Number: 1818910-2021-11123
• Device Sequence Number: 1
• Product Code: NJL
• UDI-Device Identifier: 10603295052715
• UDI-Public: 10603295052715
• 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: 05/12/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 1516-50-706
• Device Catalogue Number: 151650706
• Device Lot Number: 9292056
• Initial Date Manufacturer Received: 05/12/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; ATTUNE RP TIB BASE SZ 8 CEM; COMPETITOR CEMENT; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM LT SZ 7 CEM; ATTUNE PS RP INSRT SZ7 6MM; ATTUNE RP TIB BASE SZ 8 CEM; COMPETITOR CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR