MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FB INSRT SZ 8 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-20-810
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	03/17/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Initial reporter occupation: lawyer.(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
On (b)(6) 2014, the patient underwent total right knee arthroplasty due to degenerative joint disease.The patella was resurfaced.The surgeon reported no intraoperative complications.The patient was implanted with the attune knee system and smartset bone cement x 2.On (b)(6) 2016, the patient underwent a right knee revision due to loss of function, mid-flexion instability, and pain.The surgeon reported the tibial and femoral components were well-fixed.The surgeon indicated the patella tracked well and was retained after resizing the tibial insert.The surgeon reported no intraoperative complications.The patient was implanted with depuy tibial insert fixed bearing cruciate retaining.Doi: (b)(6) 2014.Dor: (b)(6) 2016, (rt 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.E3 initial reporter occupation: lawyer.
Event or Problem Description
Medical records received indicated that on (b)(6) 2016, the patient underwent a first right knee revision.In addition to the previously indicated issues, the patient was also experiencing pcl deficiency.Tibial insert exchanged completed.Task created to update pc.On (b)(6) 2020, the patient underwent a second right knee revision to address pain, scar removal, and tibial tray loosening at the cement to implant interface.The tibial tray, tibial insert, and femoral component were revised.The patella component was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.Task initiated to create new pc to capture second revision.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ATTUNE CR FB INSRT SZ 8 10MM
• 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: 9497124
• Report Number: 1818910-2019-124118
• Device Sequence Number: 2079277
• Product Code: JWH
• UDI-Device Identifier: 10603295046042
• UDI-Public: 10603295046042
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/09/2018

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: 1516-20-810
• Device Catalogue Number: 151620810
• Device Lot Number: 514556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 08/14/2020; 12/07/2021
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 08/17/2020; 01/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2014
• 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 FEM RT SZ 8 CEM.; ATTUNE FB TIB BASE SZ 8 CEM.; ATTUNE MEDIAL DOME PAT 38MM.; SMARTSET HV BONE CEMENT 40G.; SMARTSET HV BONE CEMENT 40G.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male