MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM RT SZ 4 CEM; ATTUNE IMPLANT : KNEE FEMORAL

Model Number 1504-00-204

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Edema (1820); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); No Code Available (3191)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Concomitant med products: attune fb tib base sz 3 cem knee tibial tray component; attune cr fem rt sz 4 cem knee femur component; attune cr fb insert sz 4 7mm knee tibial insert component; attune medial dome pat 32mm knee patella component; unknown bone cement.

Event Description

It was reported that patient has painful knee with limited motion.Doi: (b)(6) 2014 dor: (b)(6) 2018 right knee.

Manufacturer Narrative

Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4) is used to capture the surgical intervention and medical device removal.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received ad 17 june 2019.On (b)(6) 2014, the patient underwent a right knee manipulation under anesthesia due to pain, discomfort, stiffness, swelling, and arthrofibrosis.No products were revised during the procedure.On (b)(6) 2018, the patient underwent a right knee revision due to stiffness and tibial tray loosening at the cement to implant interface.The patella was not revised.Competitor cement was used during the primary operation.Doi: (b)(6) 2014; doe: (b)(6) 2014; dor: (b)(6) 2018; right knee.

Manufacturer 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.H10 additional narrative: added: h6 (patient code).Corrected: g1, g2.

• Brand Name: ATTUNE CR FEM RT SZ 4 CEM
• Type of Device: ATTUNE IMPLANT : KNEE FEMORAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork, munster ; EI
• MDR Report Key: 7901339
• MDR Text Key: 121440330
• Report Number: 1818910-2018-70134
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295041191
• UDI-Public: 10603295041191
• Combination Product (y/n): N
• PMA/PMN Number: K101433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 1504-00-204
• Device Catalogue Number: 150400204
• Device Lot Number: 390031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR BONE CEMENT.; COMPETITOR BONE CEMENT.
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR