MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 6 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-607
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscular Rigidity (1968); Pain (1994)
Date of Event	12/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # pc-(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 notification received for revision to address pain and stiffness.Date of implantation: (b)(6) 2015.Date of revision: (b)(6) 2021.(right knee) treatment: revision of tibial tray and tibial insert.
Additional Manufacturer Narrative
Product complaint (b)(4).Additional information provided from medical record review, indicates the patient received a revision, due to tibial tray loosening at the cement, to implant interface and migration.It is reasonable to conclude, that the device reported on this medwatch would not cause or contribute to the reported serious injury/revision.As the tibial insert doesn¿t have any interaction between the cement and tibial component.And the tibial insert must be removed to address the loosening.It is also reasonable to conclude, the reported pain and stiffness are secondary to the confirmed revision.The tibial tray component was reported on report number 1818910-2022-01880.At this time depuy synthes joint reconstruction considers, the device on this report to be not reportable.

• Brand Name: ATTUNE CR FB INSRT SZ 6 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13387275
• Report Number: 1818910-2022-01879
• Device Sequence Number: 20058056
• Product Code: JWH
• UDI-Device Identifier: 10603295045786
• UDI-Public: 10603295045786
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 1516-20-607
• Device Catalogue Number: 151620607
• Device Lot Number: 240604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE C/RET FEM RT SZ 6 CEMENTED; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 126 KG