MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Catalog Number 545032500

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

Patient Problems Pain (1994); Joint Laxity (4526); Unspecified Tissue Injury (4559)

Event Date 10/19/2023

Event Type  Injury  

Event Description

Patient complains of painful tka with instability noted on exam.A thicker insert trial was attempted which addressed the instability, however the patient had significant patella baja rendering the knee to be unacceptable in the surgeons opinion.All component were removed, joint line was shifted distally and revision took place uneventfully.No patient harm occurred.The index procedure was performed with trumatch guides all components were appropriately sized , aligned and were well fixed.No poly wear was noted.No delay occurred.Doi: (b)(6), 2020.Dor: (b)(6), 2023.Affected side: right knee.

Manufacturer Narrative

Product complaint # (b)(4).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.

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: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18046153
• MDR Text Key: 327022175
• Report Number: 1818910-2023-22126
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 545032500
• Device Lot Number: 9418041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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: ATTUNE CR FB INSRT SZ 4 12MM.; ATTUNE CR FEM RT SZ 4 CEM.; ATTUNE FB TIB BASE SZ 4 CEM.; ATTUNE MEDIAL DOME PAT 35MM.; DEPUY/CMW 2G.; DEPUY/CMW 2G.; DEPUY/CMW 2G.
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 53 KG