MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 SMARTSET MV 40G - EO; BONE CEMENT : BONE CEMENT

Catalog Number 3122040

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Osteolysis (2377); Not Applicable (3189)

Event Date 01/08/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Reviewed medical records received 11 may 2018.Left knee revised to address pain and aseptic tibial base plate loosening.Revising surgeon noted villonodular synovitus consistent with implant loosening.Pathology sent intraoperatively identified no acute infection.Femoral component was well-fixed.Some posterior femoral osteolysis was identified, requiring augmentation of the revised femur.The tibial base plate component was loose and came out by hand.There was no bonding of the cement to the backside of the base plate.The bone cement was well-fixed to the tibia bone.The patella component tracked well and was not revised.(it is noted that the primary attune total knee arthroplasty revised in this complaint was itself a revision of a failed patellofemoral knee arthroplasty.The manufacturer of the patellofemoral knee components has not been provided.If additional information is provided, then this patellofemoral revision event may be reported.).

Manufacturer Narrative

(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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET MV 40G - EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: chad gibson ; 700 orthopaedic dr.; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7578478
• MDR Text Key: 110380457
• Report Number: 1818910-2018-61594
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 10603295168379
• UDI-Public: 10603295168379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081155
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: 3122040
• Device Lot Number: 7868182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2018
• Date Device Manufactured: 09/02/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR