MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PRO-DENSE(R) BONE GRAFT

Catalog Number 84SR-CK15

Device Problems Collapse (1099); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/10/2014

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.This mdr is part of an in-house retrospective review.

Event Description

It was reported per yu et al 2014, "injectable synthetic bone graft substitute combined with core decompression in the treatment of advanced osteonecrosis of the femoral head: a 5-year follow-up," 11/19 patients treated with pro-dense and x-ream for core decompression were deem failure due to conversion to tha.Also, 6/19 patients were deemed a failure due to progression of collapse and harris hip score of less than 70.

• Brand Name: PRO-DENSE(R) BONE GRAFT
• Type of Device: BONE GRAFT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: 1023 cherry road; memphis, TN 38117 ; 901290-566
• MDR Report Key: 5246738
• MDR Text Key: 32038473
• Report Number: 1043534-2015-00102
• Device Sequence Number: 1
• Product Code: MQV
• Combination Product (y/n): N
• PMA/PMN Number: K070437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 84SR-CK15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1