MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Pain (1994)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Patient received a right attune total knee to treat osteoarthritis.The patella was resurfaced and competitor cement x 2 was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, dysfunction, excision of heterotopic ossification involving the tibia and femur, and tibial tray loosening at the cement to implant interface.The surgeon noted bone defects involving the tibia and femur as well as scar excision.The patellar component was retained.The tibial insert, tibial tray, and femoral component were revised.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Doi: (b)(6) 2017, dor: (b)(6) 2019 right 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 PS RP INSRT SZ 4 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11604284
• Report Number: 1818910-2021-06867
• Device Sequence Number: 4205749
• Product Code: NJL
• UDI-Device Identifier: 10603295052319
• UDI-Public: 10603295052319
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2021

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 Expiration Date: 03/31/2020
• Device Model Number: 1516-50-408
• Device Catalogue Number: 151650408
• Device Lot Number: 8094491
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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 MEDIAL ANAT PAT 35MM; ATTUNE PS FEM RT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 8MM; ATTUNE RP TIB BASE SZ 4 CEM; ZIMMER PALACOS BONE CEMENT; ZIMMER PALACOS BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR