MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DEPUY CMW 1 40G; BONE CEMENT : BONE CEMENT

Catalog Number	3312040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Necrosis (1971); Impaired Healing (2378); Fluid Discharge (2686)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Subject id: (b)(6) study no: dots clinical adverse event received for: other surgical site / delayed wound healing on (b)(6) 2024, medical records note that the patient is now 6 weeks out from right knee.Clinical impression is that the patient is doing well.It was noted that the patient has a lot of adipose tissue below their knee.(b)(6) 2024 medical records not the patient¿s chief complaint is wound care, follow-up status post knee arthroplasty.The patient is on antibiotics, the patient has three at least three pockets in the wound and one is draining pus.The patient had a debridement with scalpel in the office.(b)(6) 2024 medical records note the patient is having a follow-up right knee wound.Physical examination notes there are two necrotic areas at the distal portion of their incision.The plan is for the patient to have debridement and wound vac placement.(b)(6) 2024 medical records note the patient is having a follow-up right knee superficial and drainage.Status post superficial i and d of the right knee along with wound vac placement, doing well.
Additional Manufacturer Narrative
Depuy orthopaedics is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy orthopaedics has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy orthopaedics or its employees that the report constitutes an admission that the device, depuy orthopaedics, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.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 records evaluation (mre) was not performed.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 in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DEPUY CMW 1 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; UK
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 20733159
• Report Number: 1818910-2024-24139
• Device Sequence Number: 8949611
• Product Code: LOD
• UDI-Device Identifier: 10603295168614
• UDI-Public: (01)10603295168614(17)260630(10)4248642
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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

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: 06/30/2026
• Device Catalogue Number: 3312040
• Device Lot Number: 4248642
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 73 KG