MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MEDIAL DOME PAT 29MM; ATTUNE IMPLANT : KNEE PATELLA

Catalog Number	151820029
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Unspecified Infection (1930); Pain (1994); Swelling (2091); Injury (2348); Osteolysis (2377); No Code Available (3191)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient underwent a first-stage left knee revision due to infection, pain, swelling, erythema, and fevers.The surgeon noted gross purulence encountered upon entering the knee.There was significant subsidence of the femoral component and tibial tray.The femoral component, patella component, and tibial tray were all grossly loose at both the bone to cement and cement to implant interfaces.The surgeon reported osseous erosive changes on both femoral and tibial sides.The surgeon placed an antibiotic spacer and performed an irrigation and debridement.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2016.Dor: (b)(6) 2018; left knee.
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.Product complaint # (b)(4).The device associated with the reported event was not returned to the investigation site for evaluation.Depuy synthes considers the investigation closed at this time.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 MEDIAL DOME PAT 29MM
• Common Device Name: ATTUNE IMPLANT : KNEE PATELLA
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 8917013
• Report Number: 1818910-2019-101871
• Device Sequence Number: 1812425
• Product Code: JWH
• UDI-Device Identifier: 10603295056669
• UDI-Public: 10603295056669
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K103756
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 151820029
• Device Lot Number: 5031062
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/30/2019
• 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: 55 YR