MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 3 8MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151640308
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	10/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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
Medical records received 17 june 2019 and were reviewed 27 august 2019 for mdr reportability.On (b)(6) 2017, the patient underwent left knee arthroplasty due to degenerative arthritis, patellofemoral chondrosis, and contracture.The surgeon reported no intraoperative complications and patient was transferred to recovery in excellent condition.Depuy components, and two depuy cements were utilized in the procedure.On (b)(6) 2017, the patient underwent a left knee revision due to instability and mcl repair.The surgeon indicated he was able to very easily elevate the tibial tray away from the cement.The surgeon reported no intraoperative complications.All competitor components and cement were utilized in the procedure.Doi: (b)(6) 2017.Dor: (b)(6) 2017, (lt knee).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision depuy synthes of 21 cfr, part 803.This report may be based on 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).Investigation summary = > 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ATTUNE PS FB INSRT SZ 3 8MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9076097
• Report Number: 1818910-2019-104933
• Device Sequence Number: 2665284
• Product Code: JWH
• UDI-Device Identifier: 10603295049678
• UDI-Public: 10603295049678
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: No Information
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 151640308
• Device Lot Number: 553354
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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: 57 YR