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

Model Number	3122-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Edema (1820); Muscular Rigidity (1968); Pain (1994); No Code Available (3191); Joint Laxity (4526)
Date of Event	02/16/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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
Revised due to ligamentous instability.(b)(6) 2013 primary operative notes indicate the patient received a left total knee replacement due to left knee degenerative joint disease.This procedure was completed without complication noted by the surgeon.(b)(6) 2014 procedure notes indicate the patient received a left knee manipulation under anesthesia due to left knee arthrofibrosis.(b)(6) 2014 office notes indicate the patient is status post-manipulation under anesthesia of left total knee.States his knee is now doing well with some upper quad-muscle pain.At this time labs were drawn and infection was ruled out.(b)(6) 2014 office notes indicate the patient reports feelings of continued stiffness and pain anteriorly.(b)(6) 2014 office notes reveal the patients pain is suspected to be due to ligamentous instability.(b)(6) 2015 revision notes indicate the patient received a revision left total knee arthroplasty due to failed left total knee replacement.Indications reveal the patient was experiencing pain secondary to ligamentous instability, he presented for elective revision surgery.This procedure was completed without complication noted by the surgeon.Please note, a competitor total knee was implanted at this revision.Updated 9-21-2017.
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 : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the product and lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: SMARTSET MV 20G - EO
• 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: 9491740
• Report Number: 1818910-2019-123955
• Device Sequence Number: 1878581
• Product Code: LOD
• UDI-Device Identifier: 10603295168362
• UDI-Public: 10603295168362
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K081155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2015
• 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): 08/25/2017

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 Expiration Date: 04/30/2015
• Device Model Number: 3122-020
• Device Catalogue Number: 3122020
• Device Lot Number: 3607806
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 03/16/2021
• 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 DOME PAT 38MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR