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

Model Number	1518-20-029
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Codes	Edema (1820); Scar Tissue (2060); No Code Available (3191)
Date of Event	04/08/2019
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
The patient underwent a right knee revision due to effusion, keloid removal, and tibial tray loosening at the cement to implant interface.Two depuy cement products were used during the primary operation.The surgeon indicated the patella component was everted and assessed to have an asymmetric cut, confirmed by x-ray.However, the patellar cut was so thin already that the surgeon decided not to revise the patellar component for fear of causing a devastating complication.The patellar and femoral components were well-fixed and retained.Doi: (b)(6) 2016, 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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• 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: 10488176
• Report Number: 1818910-2020-19371
• Device Sequence Number: 2794903
• Product Code: JWH
• UDI-Device Identifier: 10603295056669
• UDI-Public: 10603295056669
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 1518-20-029
• Device Catalogue Number: 151820029
• Device Lot Number: 7807115
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/04/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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 29MM; ATTUNE PS FB INSRT SZ 4 5MM; ATTUNE PS FEM RT SZ 4 NAR CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 29 MM; ATTUNE PS FB INSRT SZ 4 5 MM; ATTUNE PS FEM RT SZ 4 NAR CEM; SMARTSET HV BONE CEMENT 40G; SMARTSET HV BONE CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR