MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Model Number 5450-32-500

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Edema (1820); Muscular Rigidity (1968); Pain (1994); No Code Available (3191)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient presented for post-primary evaluations of the left knee on (b)(6) 2018 and (b)(6) 2018.The patient complained of pain, "snapping, cracking, and popping" of the knee, swelling, and stiffness.X-ray images showed the components to be intact, aligned, and with no fractures.The physician indicated he suspected tibial tray loosening.There is no evidence of revision or intervention.Three depuy cement products were used during the primary operation.Doi: (b)(6) 2016; doe: (b)(6) 2018; left knee.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : update 24-feb-2021: the investigation was re-opened upon receipt of additional information.No device associated with this report was received for examination.Visual examination of the provided photographs confirmed the reported event.Based on previous investigations, this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Device history lot : device history reviewed on (date) 1 unrelated non-conformances on this lot number.Final micro and sterility tests passed.(b)(4) units released.Lot expiry date: 31 mar 19.There were no anomalies identified on this lot.Dmf# - 13704 , trade name ¿ gentamicin sulphate , active ingredient(s) ¿ gentamicin sulphate , dosage form - powder , strength ¿ 1.0g active in our cements.

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 9830224
• MDR Text Key: 188219961
• Report Number: 1818910-2020-07808
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 5450-32-500
• Device Catalogue Number: 545032500
• Device Lot Number: 8283423
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 35MM; ATTUNE PS FEM LT SZ 6 NAR CEM; ATTUNE PS RP INSRT SZ 6 7MM; ATTUNE RP TIB BASE SZ 4 CEM; DEPUY/CMW 2G; DEPUY/CMW 2G; DEPUY/CMW 2G
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR