MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS LT SZ 6; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); No Code Available (3191)
Date of Event	03/06/2020
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
Clinical adverse event received for existing hydrops (edema) left knee.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2019, date of event (onset): (b)(6) 2020, (left knee).Treatment: diagnostic intervention - invasive knee aspiration for cultures to rule-out possible infection : results were negative for infection; medical treatment - left knee brace.
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 PS LT SZ 6
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10690386
• Report Number: 1818910-2020-22589
• Device Sequence Number: 2849422
• Product Code: JWH
• UDI-Device Identifier: 10603295041917
• UDI-Public: 10603295041917
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K140881
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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: 1504-11-106
• Device Catalogue Number: 150411106
• Device Lot Number: 9199510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 12/10/2020
• 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 PS RP INSRT SZ6 6MM; ATTUNE RP TIB BASE SZ 6 POR; ATTUNE PS RP INSRT SZ6 6MM; ATTUNE RP TIB BASE SZ 6 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 75