MAUDE Adverse Event Report: DEPUY CMW - 9610921 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Model Number 5450-50-501

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

Patient Problem Unspecified Infection (1930)

Event Date 09/14/2018

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 adverse event received for infected left total knee arthroplasty.Event is serious and is considered severe.Event is possibly related to device and is related to procedure.Date of implantation: (b)(6) 2018; date of event (onset): (b)(6) 2018; (left knee).Treatment: iv antibiotics, surgical i&d with revision of all femoral construct, tibial construct, insert components on (b)(6) 2018.

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: a search of the depuy nonconformance (nc) quality system was conducted.One nc was found associated with this product/lot combination unrelated to the reported event.

• Brand Name: SMARTSET GMV 40G US EO
• 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: 12704439
• MDR Text Key: 278574703
• Report Number: 1818910-2021-23667
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174295
• UDI-Public: 10603295174295
• 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: 10/15/2021

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 Model Number: 5450-50-501
• Device Catalogue Number: 545050501
• Device Lot Number: 8679576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 01/26/2022
• Supplement Dates FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2017
• 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: ATTUN REV OFFST STM ADPTR 4MM.; ATTUNE CRS FEMORAL LT SZ 7 CEM.; ATTUNE CRS RP INSRT SZ 7 6MM.; ATTUNE DIST FEM AUG SZ 7 4MM.; ATTUNE DIST FEM AUG SZ 7 4MM.; ATTUNE POS FEM AUG SZ 7 4MM.; ATTUNE POS FEM AUG SZ 7 4MM.; ATUN TIB SLV M/L 37MM FULL POR.; ATUNE PRESSFIT STR STEM12X60MM.; ATUNE PRESSFIT STR STEM16X60MM.; ATUNE REV RP TIB BASE SZ 6 CEM.; SMARTSET GMV 40G US EO.; SMARTSET GMV 40G US EO.; ATTUN REV OFFST STM ADPTR 4MM; ATTUNE CRS FEMORAL LT SZ 7 CEM; ATTUNE CRS RP INSRT SZ 7 6MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE DIST FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATTUNE POS FEM AUG SZ 7 4MM; ATUN TIB SLV M/L 37MM FULL POR; ATUNE PRESSFIT STR STEM12X60MM; ATUNE PRESSFIT STR STEM16X60MM; ATUNE REV RP TIB BASE SZ 6 CEM; SMARTSET GMV 40G US EO; SMARTSET GMV 40G US EO
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 98 KG