MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM LT SZ 10 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number	1504-10-110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); No Code Available (3191)
Date of Event	09/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
On (b)(6) 2018, the patient underwent a left knee revision due to loosening of the tibial and femoral components, and pain.The surgeon reported a lot of scar tissue around the patella and patellar tendon.He indicated the knee was very stiff and difficult to flex up.The surgeon reported the femoral component was found to be very loose and tamped off with no bone loss.There was no adherence at the femoral component to cement interface.The surgeon indicated the tibial component was completely loose at the component to cement interface.He noted the patella was found to be placed lateral and with some wear, and revised.The patient was implanted with a competitor system and there were no complications to the procedure.Primary product information can be found on page 8/17 of the attached medical records.Two depuy cement products were used during primary operation.Please add hospital account information.Awareness date is (b)(6) 2019.
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.Corrected: h6 (patient) retracting the reported code for medical device removal.

• Brand Name: ATTUNE PS FEM LT SZ 10 CEM
• Common Device Name: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9497247
• Report Number: 1818910-2019-124129
• Device Sequence Number: 13805480
• Product Code: JWH
• UDI-Device Identifier: 10603295041672
• UDI-Public: 10603295041672
• 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
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: 06/30/2024
• Device Model Number: 1504-10-110
• Device Catalogue Number: 150410110
• Device Lot Number: 552650
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 08/31/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR