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

Catalog Number 3095040

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

Patient Problem Synovitis (2094)

Event Date 04/20/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Dmf#: (b)(6), 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 patch of synovitis lateral aspect of left knee.Event is not serious and is considered mild.Event is not related to device and possibly related to procedure.Date of implant: (b)(6) 2018, date of event: (b)(6) 2021, (left knee).Treatment: unspecified injected medication and diagnostic intervention.

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.

• Brand Name: SMARTSET GHV GENTAMICIN 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: 12786760
• MDR Text Key: 280579299
• Report Number: 1818910-2021-24753
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• 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: 8686274
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ATTUNE CRS FEMORAL LT SZ 6 CEM; ATTUNE CRS RP INSRT SZ 6 8MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATTUNE DIST FEM AUG SZ 6 4MM; ATUN FEM SLV M/L 30MM HALF POR; ATUN TIB SLV M/L 37MM HALF POR; ATUNE PRESSFIT STR STEM10X60MM; ATUNE PRESSFIT STR STEM14X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; SMARTSET GHV GENTAMICIN 40G
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 93 KG