MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 29MM; ATTUNE IMPLANT : KNEE PATELLA

Model Number	1518-20-029
Medical Device Problem Codes	Malposition of Device (2616); Appropriate Device Problem Term/Code Not Available (3191); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373); No Code Available (3191)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device: patella clunk, patella tilt.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
The patient underwent a left knee revision due to pain, patella maltracking, crepitus, and tibial tray loosening at the cement to implant interface.The patella was noted to track with significant lateral tilt and there was contact of the lateral patella bone with the femoral component.Doi: (b)(6) 2017; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).
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.H6 patient code: no code available (3191) used to capture the joint crepitation, medical device removal and surgical intervention.

• Brand Name: ATTUNE MEDIAL DOME PAT 29MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9395953
• Report Number: 1818910-2019-119009
• Device Sequence Number: 2790064
• Product Code: JWH
• UDI-Device Identifier: 10603295056669
• UDI-Public: 10603295056669
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2018

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: 06/30/2018
• Device Model Number: 1518-20-029
• Device Catalogue Number: 151820029
• Device Lot Number: 5763831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 10/15/2020
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 12/02/2019; 10/16/2020
• 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: 54 YR