MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE POS FEM AUG SZ 4 8MM; KNEE FEMORAL ACCESSORY

Model Number	1549-04-002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	06/10/2021
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
Revision for fracture.This procedure was a second revision.The fracture was a "small fracture line" and could have occurred at the time of revision or early ambulation.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary :no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.
Event or Problem Description
Additional information received indicated that the small fracture line that appeared in x-rays was in the bone.

• Brand Name: ATTUNE POS FEM AUG SZ 4 8MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12063546
• Report Number: 1818910-2021-13544
• Device Sequence Number: 3960047
• Product Code: JWH
• UDI-Device Identifier: 10603295383048
• UDI-Public: 10603295383048
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 1549-04-002
• Device Catalogue Number: 154904002
• Device Lot Number: J2401Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/10/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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 CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE POS FEM AUG SZ 4 8MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUN FEM SLV M/L 30MM FULL POR; ATUN PRESSFIT STR STEM14X110MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 3 CEM; CEMENT MFG AND PRODUCT NAME UNKNOWN; ATTUNE CRS FEMORAL RT SZ 4 CEM; ATTUNE CRS RP INSRT SZ 4 8MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE DIST FEM AUG SZ 4 12MM; ATTUNE POS FEM AUG SZ 4 8MM; ATTUNE POS FEM AUG SZ 4 8MM; ATUN FEM SLV M/L 30MM FULL POR; ATUNE PRESSFIT STR STEM16X60MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR