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

Catalog Number	71271560
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	04/01/2018
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8034067
• Report Number: 1020279-2018-02330
• Device Sequence Number: 13834281
• Product Code: LOD
• UDI-Device Identifier: 00885556582213
• UDI-Public: 00885556582213
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K143134
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 71271560
• Device Lot Number: 218996
• Initial Date Received by Manufacturer: 10/15/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention