MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE PS FEM RT SZ 3 NAR CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-10-223

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Joint Disorder (2373); No Code Available (3191)

Event Date 12/21/2015

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.(b)(4).

Event Description

On (b)(6) 2015, the patient underwent a left attune primary tka with revision of a unicompartmental prosthesis of unknown manufacturer and a right primary attune tka with depuy cement.On (b)(6) 2015, the patient underwent a right revision due to rotational instability causing the tibial component to sublux posteriorly disengaging the posterior post.The surgeon could not determine the cause of the rotational instability.The surgeon noted a small fracture on the medial condyle of the femur.Doi: (b)(6) 2015; dor: (b)(6) 2015.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> the device associated with the reported event was not received at 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.

Event Description

Medical records received (b)(6) 2019 and were reviewed (b)(6) 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: 21 december 2015 (rt knee).

Manufacturer Narrative

Product complaint(b)(4).Depuy synthes is submitting this report pursuant to the provisions 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.H10 additional narrative: added: b5, b7, h6 (no code available (3191) is used to capture the medical device removal).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with the reported event was not received at 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.

• Brand Name: ATTUNE PS FEM RT SZ 3 NAR CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 8490982
• MDR Text Key: 141173982
• Report Number: 1818910-2019-90014
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041825
• UDI-Public: 10603295041825
• Combination Product (y/n): N
• PMA/PMN Number: K111433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 1504-10-223
• Device Catalogue Number: 150410223
• Device Lot Number: 515102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR