MAUDE Adverse Event Report: DEPUY CMW - 9610921 UNK CEMENT SMARTSET MV; BONE CEMENT

Catalog Number UNK CEMENT SMARTSET MV

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Pain (1994)

Event Date 11/24/2020

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

Patient was revised for implant loosening and pain.Explanted the attune femoral and attune fixed bearing tibial component.There was no cement under the tibial tray.Cement interface was with bone.Femur had cement in the distal area but not under the anterior flange and posterior condyles.Implanted attune rev rp tibia with sleeve and pressfit stem.Implanted an attune crs femur with sleeve, augments and pressfit stem.Patella was still intact and not revised.

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.Device history lot: product / lot information is not available.

• Brand Name: UNK CEMENT SMARTSET MV
• Type of Device: BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10980349
• MDR Text Key: 220633100
• Report Number: 1818910-2020-26660
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CEMENT SMARTSET MV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 6 CEM.; ATTUNE PS FB INSRT SZ 5 5MM.; ATTUNE PS FEM LT SZ 5 CEM.; UNK ATTUNE KNEE PATELLA.; UNK CEMENT SMARTSET MV.; ATTUNE FB TIB BASE SZ 6 CEM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM LT SZ 5 CEM; UNK ATTUNE KNEE PATELLA
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 82