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

Model Number	3102-080
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	02/22/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Patient was revised due to fall about 1 year ago, has been painful since and loosening of the tibial base fb component at the cement to implant interface.Depuy cement was used.Intra-op failed tibial component.Doi: (b)(6) 2014 dor: (b)(6) 2021 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.

• Brand Name: SMARTSET MV ENDURANCE 80G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 11446316
• Report Number: 1818910-2021-04744
• Device Sequence Number: 4523398
• Product Code: LOD
• UDI-Device Identifier: 10603295168355
• UDI-Public: 10603295168355
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3102-080
• Device Catalogue Number: 3102080
• Device Lot Number: 7868183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM RT SZ 5 NAR CEM; SMARTSET MV ENDURANCE 80G; ATTUNE FB TIB BASE SZ 3 CEM; ATTUNE PS FB INSRT SZ 5 5MM; ATTUNE PS FEM RT SZ 5 NAR CEM; SMARTSET MV ENDURANCE 80G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 107