MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SORBIE QUESTOR TOTAL ELBOW; SMALL JOINT COMPONENT

Catalog Number 80X-XXXX

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

If was reported per simcock and evans 2016, "in total elbow arthroplasty, innovative implants are bringing new revision options," that a representative case study of a (b)(6) patient who presented to the hospital with pain and loss of function of the elbow in dominant arm.Five years earlier patient had sustained a closed distal humerus fracture that was treated with plate fixation and off-label use of prosthesis for hemiarthroplasty.Patient returned to work but had increasing pain in the affected elbow over time.Radiographs demonstrated clear loosening of the prosthesis.Patient had a negative preoperative workup for infection and elected to proceed with revision.Bone resection was necessary.Three months post-op patient is back to nearly full range of motion.No further details are known at this time.

Manufacturer Narrative

This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.

• Brand Name: SORBIE QUESTOR TOTAL ELBOW
• 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 ; 901290-566
• MDR Report Key: 5548390
• MDR Text Key: 41912027
• Report Number: 1043534-2016-00022
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 80X-XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/16/2016
• Event Location: Other
• 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