MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-50-514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/21/2021
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
It was reported that the patient developed and infection for unknown reasons.Components were explanted and antibiotic spacer was placed.Doi: (b)(6) 2021, dor: (b)(6) 2021 left knee.
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 : product code 151650514, work order (b)(4) was manufactured on 09 june 2019.(b)(4) parts were manufactured per specification and all raw materials met specification.One parts from work order (b)(4) was scrapped.There is no correlation between this scrap reason and the failure mode of the complaint.There was no material reprocessing reports (mrr) associated with work order (b)(4).There were no non-conformances associated with this lot.Certificate of irradiation was review for shipment (b)(4) and met specification.

• Brand Name: ATTUNE PS RP INSRT SZ 5 14MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 12306504
• Report Number: 1818910-2021-17562
• Device Sequence Number: 14667771
• Product Code: NJL
• UDI-Device Identifier: 10603295052487
• UDI-Public: 10603295052487
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 1516-50-514
• Device Catalogue Number: 151650514
• Device Lot Number: 9175667
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/09/2021
• 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 LT SZ 5; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 7 POR; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN); ATTUNE FEM POR PS LT SZ 5; ATTUNE PS RP INSRT SZ 5 14MM; ATTUNE RP TIB BASE SZ 7 POR; BONE CEMENT (MFG. AND PRODUCT NAME UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention