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

Model Number	1547-08-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/21/2019
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 low back pain.Event is serious and is considered moderate.There is a remote possibility that the adverse event is related to device and is definitely not related to procedure.Date of implantation: (b)(6) 2018.Date of event (onset): (b)(6) 2019.(left knee).Treatment: radiation.
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).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE DIST FEM AUG SZ 8 4MM
• Common Device Name: KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11744522
• Report Number: 1818910-2021-09142
• Device Sequence Number: 16484533
• Product Code: JWH
• UDI-Device Identifier: 10603295382850
• UDI-Public: 10603295382850
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2021

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: 1547-08-001
• Device Catalogue Number: 154708001
• Device Lot Number: HN7192
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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 LT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE PS RP INSRT SZ 8 10MM; ATTUNE REVISION PRESSFIT STR STEM10X60MM; ATTUNE REVISION PRESSFIT STR STEM12X60MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE REV RP TIB BASE SZ 7 CEM; COPAL BONE CEMENT; COPAL BONE CEMENT; ATTUNE CRS FEMORAL LT SZ 8 CEM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE DIST FEM AUG SZ 8 4MM; ATTUNE PS RP INSRT SZ 8 10MM; ATTUNE REVISION PRESSFIT STR STEM10X60MM; ATTUNE REVISION PRESSFIT STR STEM12X60MM; ATUN FEM SLV M/L 35MM FULL POR; ATUN TIB SLV M/L 37MM FULL POR; ATUNE REV RP TIB BASE SZ 7 CEM; COPAL BONE CEMENT; COPAL BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 96