MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM RT SZ 3 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-203
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	02/12/2019
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
Patient received a right primary attune tka to treat advanced end-stage osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a revision of the right knee to treat pain and suspected loosening.The femoral component and tibial tray had minimal loosening but were revised due to unspecified ¿soft tissue appearance¿.The loosening interface was unknown.There was no reported product problem with the explanted tibial insert.The patella was well-fixed and retained.The patient received depuy tc3 revision products utilizing unknown cement.The procedure was completed without complications.Doi: (b)(6) 2017.Dor: (b)(6) 2019; 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.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: ATTUNE PS FEM RT SZ 3 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10087705
• Report Number: 1818910-2020-12508
• Device Sequence Number: 2462035
• Product Code: JWH
• UDI-Device Identifier: 10603295041740
• UDI-Public: 10603295041740
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 1504-10-203
• Device Catalogue Number: 150410203
• Device Lot Number: 8313659
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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 3 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 3 5MM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 32MM; ATTUNE PS FB INSRT SZ 3 5MM; SMARTSET MV 40G - EO; SMARTSET MV 40G - EO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR