MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 4 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Local Reaction (2035); Osteolysis (2377)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
On (b)(6) 2015 the patient had a right total knee arthroplasty to address primary osteoarthritis of the right knee.Due to patient¿s poor bone stock, pins in the distal femur and in proximal tibia were not satisfactory so the plans for computer assisted surgery were abandoned.Depuy components, including depuy patella and depuy cement x1 were implanted during this procedure.There were no intraoperative complications noted.(sticker page 7 of 12).On (b)(6) 2018, the patient had a revision of right total knee arthroplasty to address failed total right knee.During the procedure the surgeon observed hypertrophic synovial tissue, gross loosening of the tibial component along with subsidence.The loosening of the tibial tray was at the implant/cement interface.The femoral component was found to be loose (no interface), varus malalignment and osteolytic area of bone.The patella was not revised.Depuy components, including depuy cement x2 were implanted during this procedure.(part/lot page 12 of 12).Doi: (b)(6) 2015 dor: (b)(6) 2018 (right knee).
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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 PS RP INSRT SZ 4 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11618500
• Report Number: 1818910-2021-07106
• Device Sequence Number: 19653187
• Product Code: NJL
• UDI-Device Identifier: 10603295052302
• UDI-Public: 10603295052302
• 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: 2015
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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: 11/30/2017
• Device Model Number: 1516-50-407
• Device Catalogue Number: 151650407
• Device Lot Number: 3540565
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 09/14/2021
• 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 DOME PAT 32MM; ATTUNE PS FEM RT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 7MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET MV 40G - EO; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FEM RT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 7MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR