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	Adhesion(s) (1695); Pain (1994); No Code Available (3191)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: laywer.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 received a left primary attune system for unknown reasons.The patella was resurfaced and depuy cement x1 was utilized.The primary operative notes were not provided.Patient received a left revision to treat pain secondary to loosening of the tibial tray.Upon entering the joint, the surgeon encountered and removed scar tissue.The tibial tray was grossly loose at an unknown interface.The femoral component was well-fixed but revised.There was no reported product problem with the explanted tibial insert.The patella was retained.The patient was revised with competitor products.The procedure was completed without complications.Doi: (b)(6) 2014.Dor: (b)(6) 2019; left knee.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 = device history reviewed on 19 dec 19 4 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET MV ENDURANCE 80G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 9981921
• Report Number: 1818910-2020-11073
• Device Sequence Number: 11851034
• Product Code: LOD
• UDI-Device Identifier: 10603295168355
• UDI-Public: 10603295168355
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2020

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 Expiration Date: 11/30/2016
• Device Model Number: 3102-080
• Device Catalogue Number: 3102080
• Device Lot Number: 7786781
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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 MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ4 6MM; ATTUNE RP TIB BASE SZ 3 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ4 6MM; ATTUNE RP TIB BASE SZ 3 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR