MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER

Device Problem Device Slipped (1584)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown radial stem.Part#, lot# and udi # is not available.Device is not expected to be returned for manufacturer review/investigation.This report is for one (1) unknown radial stem.Pma/510(k) number is not available.(b)(4).Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2016, the patient underwent a partial elbow arthroplasty utilizing a radial head prosthesis system to repair a left radial head fracture on the outstretched left hand due to fall.The patient began experiencing increasing pain and diminished motion.X-ray result showed apparent loosening of the prosthesis.On (b)(6) 2017, a patient underwent a revision surgery of the radial head prosthesis system, as well as a carpometacarpal joint arthroplasty of the left thumb.During the procedure, the surgeon specifically noted that as the patient¿s forearm was rotated, the radial head stayed in position and the stem just rotated within the radial shaft, indicating that it was completely loose.The surgeon had to remove approximately 2mm of bone secondary to bone loss.This report is for one (1) unknown radial stem this is report 1 of 2 for (b)(4).

• Type of Device: PROSTHESIS, ELBOW, HEMI-RADIAL, POLYMER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 8298062
• MDR Text Key: 134778701
• Report Number: 2939274-2019-56220
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1124-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention