MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE RP TIB BASE SZ 2 CEM; ATTUNE IMPLANT : KNEE TIBIAL TRAY

Model Number	1506-10-002
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	12/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 left primary attune to treat pain secondary to degenerative joint disease.The patella was resurfaced and depuy cement x 1 was utilized.The surgeon notes the patient had gross natural laxity to varus and valgus stressing.The surgeon elected to place the components to match the patient¿s natural ligamentous laxity.The procedure was completed without complications.Patient received a left tka revision to treat pain secondary to loosening.The tibial tray was loosened and debonded at the cement to implant interface.The patella was well-fixed and retained.The femoral component was well-fixed and revised.There was no reported product problem with the revised tibial insert.The patient was implanted with competitor products.The procedure was completed without complications.Doi: (b)(6) 2018.Doi: (b)(6) 2019; left 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 RP TIB BASE SZ 2 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10334013
• Report Number: 1818910-2020-17007
• Device Sequence Number: 951779
• Product Code: NJL
• UDI-Device Identifier: 10603295042563
• UDI-Public: 10603295042563
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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 Model Number: 1506-10-002
• Device Catalogue Number: 150610002
• Device Lot Number: 8683654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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 MEDIAL ANAT PAT 32MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 7MM; DEPUY CMW 1 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR