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

Catalog Number 3095040

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

Patient Problem Unspecified Infection (1930)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).No 510k as device is not marketed in the united states under this product code, but the same/similar product is marketed in the us under a different product code.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 adverse event received for low grade infect.Event is serious and is considered severe.Event is probably related to device and is probably related to procedure.Date of implantation: (b)(6) 2018.Date of event (onset): (b)(6) 2021.(right knee).Treatment: revision of tibial base plate, tibial stem, tibial insert, and femur components.

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: bfarm dhr review was performed for product/lot combination 3095040/8801946.1) quantity manufactured: (b)(4).2) date of manufacture: 11-may-2018.3) any anomalies or deviations identified in dhr: one unrelated nc ((b)(4)) was found.There is no correlation to the reported event.4) expiry date: 30-apr-2020.5) ifu reference: (b)(4).

• Brand Name: SMARTSET GHV GENTAMICIN 40G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd.; blackpool IN 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: 13000845
• MDR Text Key: 282203574
• Report Number: 1818910-2021-27841
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 3095040
• Device Lot Number: 8801946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 02/01/2022
• Supplement Dates FDA Received: 01/11/2022; 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• 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 CEMENTED STEM 14X80MM; ATTUNE PS FB INSRT SZ 6 5MM; ATTUNE PS FEM RT SZ 6 CEM; ATUNE CRS FB TIB BASE SZ 6 CEM; SMARTSET GHV GENTAMICIN 20G; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 151 KG