MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATUN FEM SLV M/L 50MM HALF POR; KNEE FEMORAL ACCESSORY

Model Number	1511-01-106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	09/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 distal femur bone fracture, right event is serious and is considered mild.Event is definitely related to device and is probably related to procedure.Date of implantation: (b)(6) 2020, date of event (onset): (b)(6) 2020, (right knee).Treatment: open reduction internal fixation.
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.

• Brand Name: ATUN FEM SLV M/L 50MM HALF POR
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 10711499
• Report Number: 1818910-2020-22939
• Device Sequence Number: 3933614
• Product Code: JWH
• UDI-Device Identifier: 10603295436539
• UDI-Public: 10603295436539
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K160700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 1511-01-106
• Device Catalogue Number: 151101106
• Device Lot Number: J7024F
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/24/2020
• 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 CRS FEMORAL RT SZ 8 CEM.; ATTUNE CRS RP INSRT SZ 8 16MM.; ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE POS FEM AUG SZ 8 4MM.; ATTUNE POS FEM AUG SZ 8 4MM.; ATUN TIB SLV M/L 53MM FULL POR.; ATUNE REV RP TIB BASE SZ 8 CEM.; DEPUY1 GENTAMICIN CEMENT 40G.; DEPUY1 GENTAMICIN CEMENT 40G.; ATTUNE CRS FEMORAL RT SZ 8 CEM; ATTUNE CRS RP INSRT SZ 8 16MM; ATTUNE MEDIAL DOME PAT 38MM; ATTUNE POS FEM AUG SZ 8 4MM; ATTUNE POS FEM AUG SZ 8 4MM; ATUN TIB SLV M/L 53MM FULL POR; ATUNE REV RP TIB BASE SZ 8 CEM; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 125