MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-50-501

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

Patient Problems Adhesion(s) (1695); Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/09/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical adverse event received for arthrofibrosis: - stiffness/unable to get good rom.Event is not serious and is considered moderate.Event is definitely not related to both device and is definitely related to procedure.Date of implantation: (b)(6) 2020.Date of event (onset): (b)(6) 2020.(right knee).Treatment: knee manipulation under anesthesia ((b)(6) 2020).

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.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10631333
• MDR Text Key: 209963053
• Report Number: 1818910-2020-21612
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 9292945
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM.; ATTUNE PS FEM RT SZ 6 CEM.; ATTUNE PS RP INSRT SZ6 5MM.; ATTUNE RP TIB BASE SZ 5 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 91