MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY1 GENTAMICIN CEMENT 40G; BONE CEMENT : BONE CEMENT

Catalog Number	545031500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pulmonary Embolism (1498)
Date of Event	10/27/2023
Type of Reportable Event	Death
Event or Problem Description
(b)(6).Clinical adverse event received for vascular pe.Event is serious and is considered severe.Event is possibly related to procedure.Event is not related to device.Date of implant: (b)(6) 2009.Date of revision: (b)(6) 2023.Date of event: (b)(6) 2023 (right knee).Treatment: adverse event resulted in death.
Additional Manufacturer Narrative
Product complaint # (b)(4).There is limited information regarding the patient's death at this time.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The information provided regarding the manufacturing date and implantation date are identified to be conflicting.Continued follow-up is being conducted and any additional information received will be reported.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.Dmf# - (b)(4), trade name- gentamicin sulphate, active ingredient(s)- gentamicin sulphate, dosage form - powder, strength - 1.0g active in our cements.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.In order to determine if a lot related issue was possible, a worldwide complaint database search was performed.A worldwide complaint database search found no additional related reports against the provided product code/lot code combination.Based on the inability to find any additional related reports against the provided product code/lot code combination it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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
• Common Device Name: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CMW MFG & MATERIAL WAREHOUSE; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18138917
• Report Number: 1818910-2023-23222
• Device Sequence Number: 6449257
• Product Code: MBB
• UDI-Device Identifier: 10603295174264
• UDI-Public: 10603295174264
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K081163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 545031500
• Device Lot Number: 9905843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/18/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BIOMET FEMORAL COMPONENT; BIOMET TIBIAL BASE; BIOMET TIBIAL INSERT; DEPUY/CMW 2G; DEPUY1 GENTAMICIN CEMENT 40G; PFC*SIGMA/OV/DOME PAT 3PEG,38
• Outcome Attributed to Adverse Event: Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Hispanic
• Patient Race: White