MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 9 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-906
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
(b)(6) 2019: patient received a right attune total knee to treat oa.The patella wasn¿t resurfaced and cement mfg is depuy.The procedure was completed without complications.(b)(6) 2020: patient underwent a right knee revision due to pain with ambulation.There were no clinical signs of infection.The tibial tray was noted to be grossly loose at the cement to implant interface.Lateral tibial subsidence was also noted.There were no alleged product deficiencies with the femoral component or tibial insert.Competitor products were placed at revision.Doi: (b)(6) 2019.Dor: (b)(6) 2020.Right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE CR FB INSRT SZ 9 6MM
• 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: 12533006
• Report Number: 1818910-2021-21172
• Device Sequence Number: 1320773
• Product Code: JWH
• UDI-Device Identifier: 10603295046134
• UDI-Public: 10603295046134
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2021

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: 03/31/2019
• Device Model Number: 1516-20-906
• Device Catalogue Number: 151620906
• Device Lot Number: 506261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2014
• 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 CR FB INSRT SZ 9 6MM; ATTUNE CR FEM RT SZ 9 CEM; ATTUNE FB TIB BASE SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE CR FB INSRT SZ 9 6MM; ATTUNE CR FEM RT SZ 9 CEM; ATTUNE FB TIB BASE SZ 8 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male