MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number 1516-40-818

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

Patient Problems Pain (1994); Joint Laxity (4526)

Event Date 07/21/2021

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 instability and pain.Doi: (b)(6) 2017, dor: (b)(6) 2021, right knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot: a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: ATTUNE PS FB INSRT SZ 8 18MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12308047
• MDR Text Key: 266038297
• Report Number: 1818910-2021-17600
• Device Sequence Number: 1
• Product Code: OIY
• UDI-Device Identifier: 10603295050421
• UDI-Public: 10603295050421
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• 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: 07/21/2021

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: 1516-40-818
• Device Catalogue Number: 151640818
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2021
• Initial Date FDA Received: 08/11/2021
• Supplement Dates Manufacturer Received: 08/24/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE CEMENTED STEM 14X50MM; ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE PS FEM RT SZ 8 CEM; ATUNE CRS FB TIB BASE SZ 8 CEM; ATTUNE CEMENTED STEM 14X50MM; ATTUNE PS FB INSRT SZ 8 18MM; ATTUNE PS FEM RT SZ 8 CEM; ATUNE CRS FB TIB BASE SZ 8 CEM
• Patient Outcome(s): Required Intervention