MAUDE Adverse Event Report: SMITH & NEPHEW, INC. VERSABOND 40 GRAM F2; BONE CEMENT

Catalog Number UNKN01200803

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Event Description

*literature case* "application of bone cement mixed with allogeneic bone powder in bone defect reconstruction of limb bone tumers".Authors: chang zhiyong liu xin yao chen li dong geng ze zhang xingquan.It was documented in this study, there was a patient, (b)(6)year-old male, was at first diagnosed with femoral fibrous dysfunction with pathological fractures, and underwent surgery again at another hospital.The device used in the patient was pmma bone cement.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation, therefore the failure could not be confirmed.The clinical/medical team concluded, per the article (author, chang zhiyon et al.) a 4-yr old patient diagnosed with femoral fibrous dysfunction with pathological fractures had bone recon with pmma + allogeneic bone powder and experienced recurrence which was treated with another surgery at an osh.Without clinically relevant patient-specific supporting documentation, the root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: VERSABOND 40 GRAM F2
• Type of Device: BONE CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10260733
• MDR Text Key: 198492832
• Report Number: 1020279-2020-03071
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

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: UNKN01200803
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other