MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-31-500

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Unspecified Infection (1930); Pain (1994); Synovitis (2094); Swelling/ Edema (4577)

Event Date 10/19/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Dmf# - (b)(4), 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

Clinical notification received for revision of right total knee to address infection.Date of implantation: (b)(6) 2018.Date of revision #1: (b)(6) 2020.Date of revision #2: (b)(6) 2021 (right knee).Treatment: all products explanted and antibiotic spacer placed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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).A manufacturing records evaluation (mre) was not performed.

Event Description

The patient underwent a right knee revision to address infection, pain, swelling, synovitis, removal of fibrous tissue, and tibial component loosening.The surgeon had to perform a coronal plane osteotomy of the distal femur to remove the well-fixed femoral components.There was noted to be removal of cerclage wires on the femur that were placed prior for an unknown reason on an unknown date.It is unknown if the wires were previously placed due to a complication or to prevent any issues.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12863154
• MDR Text Key: 281164435
• Report Number: 1818910-2021-26245
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-31-500
• Device Catalogue Number: 545031500
• Device Lot Number: 8662882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2017
• 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
• Treatment: DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; DEPUY1 GENTAMICIN CEMENT 40G; MBT REVISION CEM TIB TRAY SZ 4; MBT TRAY SLEEVE POR M/L 61MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC SIGMA FEM POST AUG SZ5 8MM; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA DIS AUG 4MM,SZ5,RGHT; PFC*SIGMA TC3 FEM RT SZ5; PFC*SIGMA/OV/DOME PAT 3PEG,38; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; TC3 RP TIBIAL INSERT S5,25.0; UNIVERSAL FEM SLV DIS POR 46MM; UNIVERSAL STEM 115X14MM FLUTED; UNIVERSAL STEM 75X20MM FLUTED
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White