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

Model Number	1504-10-103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/17/2016
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 left primary attune tka to treat end-stage osteoarthritis.The patella was resurfaced, and depuy cement x 2 was utilized.The surgeon noted that the patient had posterolateral insufficiency due to an old acl injury and that the popliteus tendon was absent.The procedure was completed without complications.Patient receive a left total revision to treat pain and instability.Upon entering the joint, the surgeon confirmed gross instability of the left knee.The tibial tray and femoral component were well-fixed but revised.There was no reported product problem with the explanted tibial insert.The patella was retained.The surgeons note the patellar tendon was thinning at the tibial tubercle and was reattached with suture.The patient received competitor revision products utilizing competitor cement.The procedure was completed without complications.Doi: (b)(6) 2015.Dor: (b)(6) 2016; 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 PS FEM LT SZ 3 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10130017
• Report Number: 1818910-2020-13336
• Device Sequence Number: 2116453
• Product Code: JWH
• UDI-Device Identifier: 10603295041603
• UDI-Public: 10603295041603
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 11/30/2022
• Device Model Number: 1504-10-103
• Device Catalogue Number: 150410103
• Device Lot Number: 322468
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 07/13/2020
• 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 DOME PAT 38MM; ATTUNE PS FEM LT SZ 3 CEM; ATTUNE PS FEM LT SZ 3 CEM; ATTUNE PS RP INSRT SZ 3 10MM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE PS FEM LT SZ 3 CEM; ATTUNE PS FEM LT SZ 3 CEM; ATTUNE PS RP INSRT SZ 3 10MM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR