MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SMARTSET GMV 40G US EO; BONE CEMENT : BONE CEMENT

Catalog Number 545050501

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

Patient Problem Pain (1994)

Event Date 05/25/2011

Event Type  Injury  

Event Description

Clinical adverse event received for severe pain.Event is not serious.Date of implant: (b)(6) 2010.Date of revision: (b)(6) 2013.Date of event: (b)(6) 2011.(left knee).Treatment: revision; femoral component, tibial base, and insert were revised.

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.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.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SMARTSET GMV 40G US EO
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17412579
• MDR Text Key: 319925947
• Report Number: 1818910-2023-15438
• 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
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 545050501
• Device Lot Number: 3572299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2013
• 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: CEM RESTRICTOR LG.; MBT REVISION CEM TIB TRAY SZ 3.; MBT TRAY SLEEVE POR M/L 37MM.; PFC MODULAR TIBIAL STEMS 15X60MM.; PFC SIGMA FEM POST AUG SZ4 4MM.; PFC SIGMA FEM POST AUG SZ4 4MM.; PFC SIGMARP STB TB IN 4 12.5.; PFC*SIGMA DIS AUG 4MM, SZ4, LEFT.; PFC*SIGMA DIS AUG 4MM, SZ4, LEFT.; PFC*SIGMA TC3 FEM LEFT SZ4.; SIG FEM ADAP +2/-2 OFFSET BOLT.; SIGMA FEM ADAPTER 5 DEGREE.; UNIVERSAL STEM 115X12MM FLUTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic