MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET MV ENDURANCE 80G; BONE CEMENT : BONE CEMENT

Model Number 3102-080

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Insufficient Information (4580)

Event Date 08/20/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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

Aseptic loosening of the patella.Original surgery done (b)(6) 2008 at rutland regional medical center by the surgeon.Right knee.Depuy cement was used - smartset mv bone cement.Doi: (b)(6) 2008, dor: unknown, right knee.

Event Description

Additional information received indicated that the surgery time was not extended and the interface was implant to cement.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material thatwould be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SMARTSET MV ENDURANCE 80G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 12460044
• MDR Text Key: 271030566
• Report Number: 1818910-2021-19922
• Device Sequence Number: 1
• Product Code: KIH
• UDI-Device Identifier: 10603295168355
• UDI-Public: 10603295168355
• Combination Product (y/n): N
• PMA/PMN Number: P960001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3102-080
• Device Catalogue Number: 3102080
• Device Lot Number: 2374507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET MV ENDURANCE 80G; PFC*SIGMA/OV/DOME PAT 3PEG,41; SMARTSET MV ENDURANCE 80G
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR