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

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Insufficient Information (4580)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Dmf# - 13704, trade name ¿ gentamicin sulphate, active ingredient(s) ¿ gentamicin sulphate, dosage form ¿ powder, strength ¿ 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Study: dots.Clinical notification received for revision of right knee unicompartmental arthroplasty to address aseptic loosening.Date of implantation: (b)(6) 2010.Date of revision: (b)(6) 2020.(right knee).Treatment: revision of competitor femur, tibial tray, and tibial insert components implants were non-depuy.Only cement was depuy product.

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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Event Description

On (b)(6) 2010, patient had a right medical unicompartmental replacement, competitor components were used along with depuy cement.On (b)(6) 2020, the patient had a revision right total knee to address failure of medial unicompartmental replacement.Depuy components were implanted during this procedure, including depuy patella.Prior to surgery the patient was experiencing pain, and decreasing function.The findings included kellgren lawrence 4 changes lateral compartment of her knee as well as the patellofemoral articulation.There was no mention of loosening in the operative notes.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified 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:  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: 11372871
• MDR Text Key: 233970205
• Report Number: 1818910-2021-03734
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 3121784
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXFORD UNI KNEE ANAT ARCOM SML RT 3MM THK; OXFORD UNI KNEE COCR RT MED TIB TRAY STD SZ A; OXFORD UNI KNEE FEMORAL SZ SMALL
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 87