MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET HV BONE CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 3092-040

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Edema (1820); Pain (1994); No Code Available (3191)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Initial reporter occupation: lawyer.(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 received a right primary attune to treat pain and swelling secondary to osteoarthritis.The patella was resurfaced and depuy cement x 2 was utilized.The procedure was completed without complications.Patient received a right knee i & d with insert revision to treat wound drainage secondary to staph epidermidis.Upon entering the joint, the surgeon identified chronic inflammation.Synovitis and scar tissue were excised.A thorough debridement was performed, and the insert was exchanged.Competitor antibiotic pellets were placed.The patient was revised with a depuy insert.The procedure was completed without complications.The patient received 6 weeks of iv antibiotic treatment.Patient received a right knee revision to treat pain and swelling secondary to loosening of the tibial tray.Upon entering the joint, effusion was evacuated.The tibial tray was grossly loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.The patella and femoral component were retained.The patient was revised with unknown products.The procedure was completed without complications.Doi: (b)(6) 2016, dor: (b)(6) 2016 (insert), dor: (b)(6) 2020 (insert and tibial tray).

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: dhr review completed 17 sep 19.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.

• Brand Name: SMARTSET HV BONE CEMENT 40G
• 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: 10619522
• MDR Text Key: 209583033
• Report Number: 1818910-2020-21446
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295168331
• UDI-Public: 10603295168331
• Combination Product (y/n): N
• PMA/PMN Number: K033563
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: 3092-040
• Device Catalogue Number: 3092040
• Device Lot Number: 8268928
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 7 CEM.; ATTUNE MEDIAL DOME PAT 41MM.; ATTUNE PS FB INSRT SZ 7 8MM.; ATTUNE PS FEM RT SZ 7 CEM.; ATTUNE FB TIB BASE SZ 7 CEM; ATTUNE MEDIAL DOME PAT 41MM; ATTUNE PS FB INSRT SZ 7 8MM; ATTUNE PS FEM RT SZ 7 CEM
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR