MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-810
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
(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 : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: ATTUNE PS RP INSRT SZ 8 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 11744553
• Report Number: 1818910-2021-09147
• Device Sequence Number: 13793745
• Product Code: NJL
• UDI-Device Identifier: 10603295052883
• UDI-Public: 10603295052883
• 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: 1516-50-810
• Device Catalogue Number: 151650810
• Device Lot Number: 7975038
• 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