MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET HV 20G; BONE CEMENT : BONE CEMENT

Catalog Number	3092020
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); No Code Available (3191)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
Patient was revised to address pain, loss of motion and loosening of the tibial component at the cement to implant interface.
Additional Manufacturer Narrative
Product complaint #: (b)(4).This product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• 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: 8115184
• Report Number: 1818910-2018-76603
• Device Sequence Number: 16486563
• Product Code: LOD
• UDI-Device Identifier: 10603295168324
• UDI-Public: 10603295168324
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3092020
• Device Lot Number: 7786797
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2018
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR