MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-50-501

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Adhesion(s) (1695); Cyst(s) (1800); Synovitis (2094)

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.Dmf# 13704, trade name gentamicin sulphate, active ingredient(s) gentamicin sulphate, dosage form powder, strength 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Medical records received ad (b)(6) 2021 were reviewed.On (b)(6) 2014, the patient had a right total knee arthroplasty, single hamstring tendon lengthening, semimembranosus, for flexion contracture to address degenerative arthritis, varus deformity, and flexion contracture.Depuy components, including depuy patella and depuy cement x2 were used during this procedure.On (b)(6) 2019, the patient had a right revision, extensive for compartment synovectomy right knee, excision of cysts, and scar revision to address mechanical complication loosening , profound synovitis, massive cysts, debonding of the tibial tray from cement, and thickened scar tissue.Depuy components were used during this procedure, including competitor cement.During the procedure the surgeon observed cement debris.The patella was not revised.Doi: (b)(6) 2014 dor: (b)(6) 2019 (right knee).

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.Device history lot : a previous dhr review (b)(4) did not reveal any related manufacturing deviations or anomalies on the reported lot number (7786802).

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11641716
• MDR Text Key: 244686257
• Report Number: 1818910-2021-07538
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• Combination Product (y/n): Y
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 7786802
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE PS FEM RT SZ 5 NAR CEM; SMARTSET GMV 40G US EO; SMARTSET MV 40G - EO; ATTUNE FB TIB BASE SZ 4 CEM; ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FB INSRT SZ 5 6MM; ATTUNE PS FEM RT SZ 5 NAR CEM; SMARTSET GMV 40G US EO; SMARTSET MV 40G - EO
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR