MAUDE Adverse Event Report: DEPUY CMW - 9610921 CEMENT RESTRICTOR SIZE 4; HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG

Model Number 5460-16-000

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

Patient Problems Pain (1994); No Code Available (3191)

Event Date 01/23/2018

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

Medical record reports patient's follow up notes for her encounter with physician on (b)(6) 2018 as reports of ongoing pain (when attempting to stand) post revision of right total knee arthroplasty (dor (b)(6) 2017).Radiographic images give no indication of implant defects.Patient had seen a pain specialist and received a radiofrequency ablation without benefits.Physican's decision was for patient to continue therapy and further follow ups with x-rays.

Manufacturer Narrative

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

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: corrected: h6 product complaint # (b)(4).Investigation summary - no device associated with this report was received for examination.A worldwide complaint database search found no other related reported incidents against the provided product code/lot number combination since release for distribution.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 - null.Device history batch - null.Device history review - null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CEMENT RESTRICTOR SIZE 4
• Type of Device: HIP MISCELLANEOUS : CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 9511499
• MDR Text Key: 174320421
• Report Number: 1818910-2019-124570
• Device Sequence Number: 1
• Product Code: JDK
• UDI-Device Identifier: 10603295174356
• UDI-Public: 10603295174356
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5460-16-000
• Device Catalogue Number: 546016000
• Device Lot Number: H02526
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPETITOR CEMENT.; COMPETITOR CEMENT.; COMPETITOR CEMENT.
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 85