MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RALLY HV BONE CEMENT 40 GRAMS

Catalog Number 71271560

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Injury (2348)

Event Date 04/01/2018

Event Type  Injury  

Event Description

It was reported that patient has a severe pain in knee.Bone scan showed that the cement failed after just 5 months.To correct the issue, a new knee surgery has been scheduled for (b)(6) 2018 to replace the entire knee with a new product that is much more invasive.

Manufacturer Narrative

The associated complaint device was not returned.Without the actual product involved and/or device information, our investigation cannot proceed.The medical investigation concluded that the revision report did not confirm findings of loosening.Without the pre and post radiology report, bone scan report, patient clinical information, or explant, we are unable to determine the root cause of the reported loosening.The patient impact beyond the revision procedure and expected pain cannot be concluded.If the device or new information is received in the future, the complaint can be re-opened.No further actions are being taken at this time.

• Brand Name: RALLY HV BONE CEMENT 40 GRAMS
• Type of Device: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8034067
• MDR Text Key: 125983604
• Report Number: 1020279-2018-02330
• Device Sequence Number: 1
• Product Code: LOD
• UDI-Device Identifier: 00885556582213
• UDI-Public: 00885556582213
• Combination Product (y/n): N
• PMA/PMN Number: K143134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/19/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71271560
• Device Lot Number: 218996
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention