MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GHV GENTAMICIN 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-35-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Skin Discoloration (2074); Joint Laxity (4526); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Dmf# - 13704.Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder strength 1.0g active in our ce.Ments.Initial reporter occupation: lawyer.Component code: appropriate term/code not available ((b)(4)) used to capture no findings available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Radiology report (b)(6) 2017 (post revision surgery) reveals the hardware appears to be intact.There is a remote avulsion fracture of the medial aspect of the medial femoral condyle.There is no indication of treatment related to this avulsion fracture.It is unknown when this fracture occurred, during the removal of previous implants or implantation of revision implants.Therefore, this will not be captured as a separate event.Office notes (b)(6) 2017 ¿ (b)(6) 2020 indicate the patient continues to experience pain, stiffness, weakness, instability, swelling and leg length discrepancy.The patient also states she has skin discoloration on the medial aspect of her lower leg.It is indicated the surgeon has discussed the potential need for future revision, however, there is no indication an additional revision surgery has taken place.It is indicated, however, that the patient has received pain block injections due to her knee pain.A shoe heel lift was provided to help address the leg length discrepancy.Whole body bone scan was performed on (b)(6) 2019 reveals low-level activity diffusely around the left knee prosthetic.No sign of osteomyelitis or fracture.Doi: (b)(6) 2016 (patella), doi: (b)(6) 2017 (cement, insert, femoral and tibial components; captured in (b)(4)), doe: unknown.

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 = device history reviewed 24 sep 19.1 unrelated non-conformance on this lot number.Final micro and sterility tests passed.Expiry date: 31 dec 18.Quantity released: (b)(4).

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 10927388
• MDR Text Key: 219910974
• Report Number: 1818910-2020-25776
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174288
• UDI-Public: 10603295174288
• Combination Product (y/n): Y
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-35-500
• Device Catalogue Number: 545035500
• Device Lot Number: 8450225
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MBT REVISION CEM TIB TRAY S2.5; PFC SIG FEM POST AUG SZ2.5 4MM; PFC*SIGMA TC3 FEM LEFT S2.5; PFC*SIGMA/OV DOME PAT 3 PEG,32; SIG FEM ADAP +2/-2 OFFSET BOLT; SIGMA FEM ADAPTER 5 DEGREE; SMARTSET GHV GENTAMICIN 40G; TC3 RP TIBIAL INSERT S2.5,15.0; UNIVERSAL STEM 75X12MM FLUTED; UNIVERSAL STEM 75X14MM FLUTED
• Patient Outcome(s): Required Intervention