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

Model Number 5450-32-500

Device Problems Loss of or Failure to Bond (1068); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Not Applicable (3189); No Code Available (3191)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

On 04/20/2018 medical records received.After review of the medical records for mdr reportability, it was noted that the patient was revised to address ¿aseptic failure¿ and ¿loose prostheses attachments" on (b)(6) 2018.The tibial tray, femoral component, cement and insert were removed.There was no mention as to what component/s were loose or at what interface.Doi: (b)(6) 2016; dor: (b)(6) 2018; (right knee).

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4) used to capture the medical device removal.

Event Description

Medical record ad 17 june 2019 was reviewed on 12 december 2019.(b)(6) 2015: the patient underwent a right total knee arthroplasty for osteoarthritis.Attune implants were utilized with unknown manufacturer cement.Patella was resurfaced.No intraoperative complications were noted.(b)(6) 2016: the patient underwent a revision of right knee for suspected tibial tray loosening.Intraoperatively, the surgeon found tibial tray loose at implant-cement interface.The patella and femoral components were not revised.All other components (tibial and insert) were replaced with attune implants (tibial tray and insert) with depuy cement x2.No intraoperative complications were noted.(b)(6) 2018: the patient underwent a second revision of right knee for suspected tibial tray loosening.Intraoperatively, the surgeon performed a ¿near complete synovectomy as tissue was inflamed¿ but no infection.No indication if tibial tray was confirmed loose.Notes state patella button was revised but then followed by statement that it was well fixed.No indication of procedures to remove patella button.All other components were removed and replaced with depuy revision knee system with depuy cement.No intraoperative complications were noted.This complaint captures the first revision (b)(6) 2016.Doi: (b)(6) 2015.Dor: (b)(6) 2016, (tibial tray and insert).Dor (b)(6) 2018, (femoral, tibial tray, insert).

Manufacturer Narrative

Product complaint # : (b)(4).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.

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 7527075
• MDR Text Key: 108681365
• Report Number: 1818910-2018-60008
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): N
• PMA/PMN Number: K061144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 5450-32-500
• Device Catalogue Number: 545032500
• Device Lot Number: 8205478
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ATTUNE MEDIAL DOME PAT 38MM
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR