MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEM POR PS RT SZ 4; ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL

Model Number	1504-11-204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (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
Clinical adverse event received for intraoperative nondisplaced bone fracture of medial femoral condyle - at base of the ps box cut.Event is serious and is considered moderate.Event is possibly related to both device and procedure.Date of implantation: (b)(6) 2021, date of event (onset): (b)(6) 2021, (right knee).Treatment: open reduction of fracture with internal fixation using 3.5 large screws x 3.
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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE FEM POR PS RT SZ 4
• Common Device Name: ATTUNE CEMENTLESS IMPLANTS : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11870093
• Report Number: 1818910-2021-10969
• Device Sequence Number: 13683396
• Product Code: MBH
• UDI-Device Identifier: 10603295042037
• UDI-Public: 10603295042037
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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 Model Number: 1504-11-204
• Device Catalogue Number: 150411204
• Device Lot Number: 8922637
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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 FEM POR PS RT SZ 4; ATTUNE PS RP INSRT SZ4 5MM; ATTUNE RP TIB BASE SZ 4 POR; ATTUNE FEM POR PS RT SZ 4; ATTUNE PS RP INSRT SZ4 5MM; ATTUNE RP TIB BASE SZ 4 POR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 85