MAUDE Adverse Event Report: DEPUY CMW - 9610921 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	Cyst(s) (1800); Edema (1820); Pain (1994); Osteolysis (2377); No Code Available (3191)
Date of Event	04/10/2019
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 was revised to address tibia debondment.Doi: unk; 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.

• Brand Name: SMARTSET HV 20G
• 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: 9583241
• Report Number: 1818910-2020-01659
• Device Sequence Number: 3244002
• Product Code: LOD
• UDI-Device Identifier: 10603295168324
• UDI-Public: 10603295168324
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K023012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2019

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: 10/31/2016
• Device Model Number: 3092-020
• Device Catalogue Number: 3092020
• Device Lot Number: 8007473
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 09/25/2020
• 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 FEM LT SZ 5 CEM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR