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 Code	Pain (1994)
Date of Event	10/14/2019
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 primary attune tka to treat severe djd.The patella was resurfaced and competitor depuy x 1 was utilized.The surgeon notes the patient had preexisting flexion contracture and valgus deformity.The procedure was completed without complications.Patient received a left knee revision to treat pain secondary to loosening of the tibial tray.The femoral component was well-fixed but revised to accommodate the revision construct.The tibial tray was loosened and debonded at the cement to implant interface and revised.There was no reported product problem with the revised tibial insert.Patella was retained.The patient was revised with a competitor revision knee.The procedure was completed without complications.Doi: (b)(6) 2016 dor: (b)(6) 2019 left 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 : device history reviewed 11 jun 2021 1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.All qc release specifications met.(b)(4) units released.Lot expiry 31 may 2018.

• 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: 11726127
• Report Number: 1818910-2021-08741
• Device Sequence Number: 14207912
• Product Code: LOD
• UDI-Device Identifier: 10603295168355
• UDI-Public: 10603295168355
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P960001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 8134390
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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 MEDIAL ANAT PAT 32MM; ATTUNE PS FEM LT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 7MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET MV ENDURANCE 80G; ATTUNE MEDIAL ANAT PAT 32MM; ATTUNE PS FEM LT SZ 4 CEM; ATTUNE PS RP INSRT SZ 4 7MM; ATTUNE RP TIB BASE SZ 3 CEM; SMARTSET MV ENDURANCE 80G
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR