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 Pain (1994); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 09/22/2020

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

The patient was revised to address pain, mid-flexion instability and tightness in flexion.Pathology confirmed that there was no infection.All components were removed and replaced with attune revision crs with sleeves and stems.After removal of components, the surgeon confirmed that nothing was loose.Doi: (b)(6) 2018, dor: (b)(6) 2020, right knee.

Manufacturer Narrative

Product complaint # (b)(4).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.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: details for gentamicin component of combination product: dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form - powder, and strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 10621798
• MDR Text Key: 209642838
• Report Number: 1818910-2020-21503
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8751052
• 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 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FEM RT SZ 9 CEM; ATTUNE PS RP INSRT SZ9 5MM; ATTUNE RP TIB BASE SZ 9 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR