MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INBONE(R) TIBIAL BASE STEM; SMALL JOINT COMPONENT

Catalog Number 200009901

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported that during the initial surgery, the stem broke off above the tibial base."the original tibial stem was left in place and an antibiotic spacer was placed in the void for 3 months.A revision was done to place a tibial base back on the original stem." it was reported that the patient became infected.No further details are known.

• Brand Name: INBONE(R) TIBIAL BASE STEM
• Type of Device: SMALL JOINT COMPONENT
• 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 ; 901867-414
• MDR Report Key: 5166031
• MDR Text Key: 28865927
• Report Number: 1043534-2015-00062
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2015

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?: Yes
• Device Operator: Physician
• Device Catalogue Number: 200009901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/22/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/22/2015
• Initial Date FDA Received: 10/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention