MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Model Number 5450-31-500

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Pain (1994); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 04/05/2016

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

Event Description

Subject id: (b)(4).Study: dots.Clinical adverse event received for osteolysis/luciencies/migration/loosening - femoral event is serious and is considered severe event is definitely related to device and is definitely related to procedure.Date of implantation: (b)(6) 2013.Date of event (onset): (b)(6) 2016.(right knee).Treatment: osteolysis/lucencies were noted (b)(6) 2016 and which progressivly worsened until the knee was revised on (b)(6) 2017.Femur, tibial tray,and insert were revised.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Primary operative notes (b)(6) 2013 indicate the patient received a right total knee replacement due to end stage osteoarthritis.The patella was resurfaced, and depuy cement was utilized.The surgery was completed without indication of complication by the surgeon.Revision operative notes (b)(6) 2017 indicate the patient received a right total knee revision due to osteolysis, effusion and pain.Upon entering the joint, the femoral component was noted to be grossly loose.The femoral, tibial and insert components revised.The surgery was completed without indication of complication by the surgeon.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.All available x-rays and photographs were reviewed, and the reported event cannot be confirmed.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 : 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.

• Brand Name: DEPUY1 GENTAMICIN CEMENT 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• 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: 12703858
• MDR Text Key: 278553883
• Report Number: 1818910-2021-23635
• 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,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5450-31-500
• Device Catalogue Number: 545031500
• Device Lot Number: 3498649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2013
• 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: ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE RP TIB BASE SZ 8 CEM; DEPUY CMW 1 40G; DEPUY1 GENTAMICIN CEMENT 40G; ATTUNE MEDIAL ANAT PAT 41MM; ATTUNE PS FEM RT SZ 8 CEM; ATTUNE PS RP INSRT SZ 8 8MM; ATTUNE RP TIB BASE SZ 8 CEM; DEPUY CMW 1 40G; DEPUY1 GENTAMICIN CEMENT 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White