MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET HV 20G; BONE CEMENT : BONE CEMENT

Model Number	3092-020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
Date of Event	11/05/2019
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
The surgeon indicated the patient will undergo a right knee revision due to suspected tibial tray loosening when the patient is medically cleared.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2016, dor: unknown, right knee.
Event or Problem Description
Medical records received on 7 feb 2020 were reviewed to identify patient harms/product issues on 19 feb 2020.The patient underwent a right knee revision due to pain, decreased range of motion, and tibial tray loosening at the cement to implant interface.The femoral component was well-fixed but revised.The patellar component was well-fixed and retained.Two depuy cement products were used during the primary operation.Doi: (b)(6) 2016.Dor: (b)(6) 2019 right knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.  h10 additional narrative: added: b3, b5, d7, d11, h6 (no code available (3191) is used to capture the device revision or replacement); corrected: a2, b1, h1.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. .
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.H10 additional narrative: product complaint (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.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 (date) 0 non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 31 july 2017.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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 at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: SMARTSET HV 20G
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8934903
• Report Number: 1818910-2019-102314
• Device Sequence Number: 2000825
• Product Code: LOD
• UDI-Device Identifier: 10603295168324
• UDI-Public: 10603295168324
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2019

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: 07/31/2017
• Device Model Number: 3092-020
• Device Catalogue Number: 3092020
• Device Lot Number: 8158656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 01/10/2020; 02/19/2020; 10/09/2020
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 01/16/2020; 03/04/2020; 10/14/2020
• 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 CR FB INSRT SZ 5 5MM; ATTUNE CR FB INSRT SZ 5 5MM; ATTUNE CR FEM RT SZ 5 CEM; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL ANAT PAT 35MM; SMARTSET HV BONE CEMENT 40G; ATTUNE CR FB INSRT SZ 5 5MM
• Patient Age: 51 YR