MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US 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	Pain (1994); Discomfort (2330); No Code Available (3191)
Date of Event	09/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Initial reporter occupation: lawyer.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 right primary attune to treat severe osteoarthritis.Intraoperatively, the surgeon notes there was obliteration of the medial joint.The patella was resurfaced and depuy cement x 1 was utilized.The procedure was completed without complications.Patient received a right knee revision to treat pain and discomfort secondary to tibial tray loosening and migration.Upon entering the joint, the tibial tray was loosened and debonded at the cement to implant interface and easily removed.The femoral component was well-fixed and retained.The patella was well fixed and retained.There was no reported product problem with the explanted tibial insert.The patient received depuy revision components utilizing depuy cement.The procedure was completed without complications.Intraoperative pathology indicated 1 pair of gram positive cocci but 3 day growth was negative for infection.Doi: (b)(6) 2014, dor: (b)(6) 2019 right knee.
Additional 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 : a previous device history record (dhr) review (b)(4) was performed.The dhr review revealed of the (b)(4) unit batch, four unrelated non-conformances of this lot were identified.Final micro and sterility tests passed.

• Brand Name: SMARTSET MV ENDURANCE 80G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10504591
• Report Number: 1818910-2020-19566
• Device Sequence Number: 14286958
• Product Code: LOD
• UDI-Device Identifier: 10603295168355
• UDI-Public: 10603295168355
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 08/21/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/08/2020
• Supplement Report FDA Received Date: 10/06/2020
• 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 RT SZ 4 NAR CEM; ATTUNE PS RP INSRT SZ 4 10MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET MV ENDURANCE 80G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR