MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR CR LT SZ 5; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-01-105
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	02/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Usfda mdr determination: revision due to infection.The tibial insert isn't being reported as it was revised less than 2 months prior (b)(4) for a known infection.It's reasonable to conclude the insert placed in late (b)(6) 2020 didn't cause or contribute to the infection.(b)(4).Events reported in 1818910-2021-03226, 1818910-2021-03227, 1818910-2021-03228.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
The patient was revised to address recurrent infection.The implants were explanted and switched to antibiotic spacer.The poly was swapped on (b)(6) 2020.Doi: (b)(6) 2020 (femur, patella and tibia), doi: (b)(6) 2020 (insert), dor: (b)(6) 2021, left knee.
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 FEM POR CR LT SZ 5
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11342643
• Report Number: 1818910-2021-03229
• Device Sequence Number: 17078036
• Product Code: MBH
• UDI-Device Identifier: 10603295041344
• UDI-Public: 10603295041344
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 02/02/2021

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: 1504-01-105
• Device Catalogue Number: 150401105
• Device Lot Number: 9360462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/18/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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 CR RP INSRT SZ 5 14MM; ATTUNE FEM POR CR LT SZ 5; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE RP TIB BASE SZ 5 POR; ATTUNE CR RP INSRT SZ 5 14MM; ATTUNE FEM POR CR LT SZ 5; ATTUNE MEDIAL ANAT PAT 38MM; ATTUNE RP TIB BASE SZ 5 POR
• Outcome Attributed to Adverse Event: Required Intervention