MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 8 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On saturday, (b)(6), surgeon contacted the reporting sales representative to inform him that a patient had presented in clinic recently with what he suspected was an infected left knee and his plan was to do an i&d with a possible poly exchange depending on the result of lab work he had ordered for the patient.Based on signs of an infection from the lab results, surgeon elected to perform a left knee i&d/poly exchange on wednesday, (b)(6) at (b)(6) hospital.The patient¿s index surgery was perform in late 2018 at (b)(6).Surgeon exposed the knee joint and removed the index tibial insert with an osteotome and then proceeded to debride and irrigate the knee.Surgeon then trailed different poly thicknesses and elected to replace with a new tibial insert with the same thickness as the one he took out.All others components from index surgery were tested for looseness and found to be well fixed so he elected to keep them in the patient.Surgeon mentioned lab results showed signs of a strep (staph) infection.There was no delays in the case.No instrumentation broke.There was no indication by anyone that the products did not perform as they were supposed to.There was no loosening of any components.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE PS FB INSRT SZ 8 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11412106
• Report Number: 1818910-2021-04343
• Device Sequence Number: 3597594
• Product Code: JWH
• UDI-Device Identifier: 10603295050384
• UDI-Public: 10603295050384
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1516-40-810
• Device Catalogue Number: 151640810
• Device Lot Number: J0998T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FIXED BEARING TIBIAL BASE SIZE 8 CEMENTED; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 8 10MM; ATTUNE PS FEM LT SZ 8 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR