MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 9 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-10-009
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Injury (2348); Deformity/ Disfigurement (2360); No Code Available (3191)
Date of Event	11/12/2018
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
Attune knee claim record received.Claim record alleges injuries, pain, anguish, disfigurement and physical impairment.Doi: (b)(6) 2016.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.Depuy synthese 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.
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.H10 additional narrative: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: e1, h4 and h6 (device code).
Event or Problem Description
Medical records received and reviewed: patient received bilateral attune total knees due to degenerative joint disease.The right patella was resurfaced and depuy cement x 3 was utilized.There were no indicated intra-operative complications.Patient received a right knee revision to address pain, tibial tray migration, and tibial tray loosening at the cement to implant interface.The surgeon noted the revised femoral component was slightly oversized.The tibial tray, tibial insert, and femoral component were revised.The patellar component was retained.The patient was revised with competitor products and cement.There were no indicated intra-operative complications.
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 RP TIB BASE SZ 9 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10104194
• Report Number: 1818910-2020-12896
• Device Sequence Number: 835007
• Product Code: NJL
• UDI-Device Identifier: 10603295042631
• UDI-Public: 10603295042631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2020

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: 06/30/2025
• Device Model Number: 1506-10-009
• Device Catalogue Number: 150610009
• Device Lot Number: 8149639
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 05/25/2021; 08/12/2021
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/06/2020; 06/04/2021; 08/15/2021
• 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 41MM.; ATTUNE PS FEM RT SZ 9 CEM.; ATTUNE PS RP INSRT SZ9 5MM.; ATTUNE RP TIB BASE SZ 9 CEM.; DEPUY CMW 2 20G.; DEPUY CMW 2 20G.; DEPUY CMW 2 20G.; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; DEPUY CMW 2 20G; DEPUY CMW 2 20G; DEPUY CMW 2 20G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR