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

Model Number	1506-00-009
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/21/2019
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
Patient received a right attune total knee to treat advanced tricompartmental osteoarthritis of the right knee.The patella was resurfaced, and depuy cement x2 was utilized.The procedure was completed without complications.Records indicate the patient received a revision of the right knee.The indications for the revision and the components revised are unknown.There were no revision operative notes provided.Doi: (b)(6) 2016; dor: (b)(6) 2019; right knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  h10 additional narrative: added: b5, h6 (patient and device codes).Corrected: a1.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
Medical records (b)(4) medical records ad 30 mar 2020) reviewed.On (b)(6)2019, patient received a right total knee revision to address severe pain, aseptic tibial base plate implant loosening and tibial subsidence.Findings reported debonding of the cement from the tibial baseplate implant.It required no instruments to remove.The femur was well-fixed, but revised.The patella was well-fixed, tracked well, and was not worn.The patella was retained.There was no wear of the tibial insert either, but it also was revised.

• Brand Name: ATTUNE FB 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: 9865049
• Report Number: 1818910-2020-08803
• Device Sequence Number: 16882110
• Product Code: JWH
• UDI-Device Identifier: 10603295042433
• UDI-Public: 10603295042433
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K101433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2020

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: 09/30/2023
• Device Model Number: 1506-00-009
• Device Catalogue Number: 150600009
• Device Lot Number: 7794895
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 04/27/2020
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 04/17/2020; 04/27/2020
• 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 FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FB INSRT SZ 10 5MM; ATTUNE PS FEM RT SZ 10 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; ATTUNE FB TIB BASE SZ 9 CEM; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FB INSRT SZ 10 5MM; ATTUNE PS FEM RT SZ 10 CEM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR