MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 3 7MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650307
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/21/2015
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 september 2019 for mdr reportability.On (b)(6) 2015, the patient underwent total right knee arthroplasty and a revision of the left uni-compartmental arthroplasty.This pc pertains to the right knee.The surgeon utilized depuy components and two depuy cements.No complications were noted in the surgical notes.On (b)(6) 2015, the patient underwent a revision of the attune posterior stabilized rotating platform to a sigma tc3 rotating platform component with metaphyseal sleeves to address an unstable right knee.The surgeon reported that tibial component had subluxed posteriorly disengaging the posterior post.The surgeon noted that the rotational instability was of unknown etiology and decided to remove both the femur and tibial components.There was a crack noted in the medial condyle of the femur, which was ¿fixed¿ with 7.3 cancellous screw.Depuy components were placed along with 2 smartset cements during the revision.Doi: (b)(6) 2015.Dor: (b)(6) 2015 (rt knee).
Additional Manufacturer Narrative
Product complaint # = > (b)(4).This is a duplicate of 1818910-2019-90015.1818910-2019-110769 is being retracted as it is a report duplication.1818910-2019-90015 will be kept for investigational purposes.

• Brand Name: ATTUNE PS RP INSRT SZ 3 7MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 9210059
• Report Number: 1818910-2019-110769
• Device Sequence Number: 3396417
• Product Code: NJL
• UDI-Device Identifier: 10603295052166
• UDI-Public: 10603295052166
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2019

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: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 151650307
• Device Lot Number: 3550272
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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: 48 YR