MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 12MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Model Number	1516-40-712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)
Date of Event	11/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).Initial reporter occupation: lawyer.(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
(b)(6) 2017: the patient underwent a right total knee arthroplasty.Attune implants were utilized with depuy cement x2.Patella was resurfaced.No intraoperative complications were noted.(b)(6) 2018: the patient underwent a revision of the right knee for pain, mild effusion, and radiographic detection of increased bone uptake in femur and tibia.Intraoperatively, the tibia tray was found internally rotated and surgeon notes implies tibial tray loose at implant-cement interface as the component disengaged from cement mantle with one attempt while leaving cement mantle adhered to tibia.No infection.Patella was not revised.Only the tibia tray and poly insert were replaced.This is captured on (b)(4).(b)(6) 2018: patient diagnosed with right knee wound dehiscence with superficial infection.Patient received irrigation and debridement due to infection.Intraoperatively, surgeon found arthrotomy completely intact and not able to express fluid from arthrotomy itself.No implants removed at this procedure.(b)(6) 2018: patient diagnosed with infected right knee arthroplasty and receives resection of right knee arthroplasty with placement of dynamic spacer.Patient received a complete synovectomy and all components (tibia, femoral, patella, insert) were removed.Surgeon then implanted size 4 sigma femoral component and antibiotic spacer both cemented in place (cement manufacturer not identified).(b)(6) 2019: patient receives a total revision knee arthroplasty.Femoral component (implanted (b)(6) 2018) and antibiotic spacer (implanted (b)(6) 2018) both removed and replaced with non-depuy revision knee system with unidentified manufacturer cement.Doi: (b)(6) 2017.Dor: (b)(6) 2018 (tibial tray and insert).Doe: (b)(6) 2018 (irrigation and debridement).Dor: (b)(6) 2018 (revision tibial tray, revision insert, femoral, patella).Dor: (b)(6) 219 (sigma femoral).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional 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 - null.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 7 12MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9545627
• Report Number: 1818910-2020-00305
• Device Sequence Number: 16738051
• Product Code: JWH
• UDI-Device Identifier: 10603295050254
• UDI-Public: 10603295050254
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: No Information
• Device Model Number: 1516-40-712
• Device Catalogue Number: 151640712
• Device Lot Number: HP8586
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR