MAUDE Adverse Event Report: ACUMED, LLC; PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Unspecified Musculoskeletal problem (4535)

Event Type  Injury  

Event Description

In the article " anatomic monopolar press-fit radial head arthroplasty; high rate of loosening at mid-term follow up" by samra, et al., radial head arthroplasty (rha) is used for the management of unstable or unreconstructable injuries of the radial head.The authors' aim was to investigate clinical and radiographic outcomes in patients treated with the acumed anatomic radial head press-fit system for trauma.All patients who had rha for trauma were identified using theatre databases and in house computer software.All patients were operated on between january 2009-july 2015 using the acumed anatomic radial head system (acumed, hillsboro, or, usa).3 cases underwent removal of the rha (2 due to loose painful stems and 1 for stiffness).Of the cases removed, 1 had removal of the prosthesis for painful capitellar erosion and stem loosening at 18 months but continued to have ongoing pain at final follow-up and was referred for chronic pain management.One case had painful rha loosening along with capitellar erosion and ulnohumeral arthritis at 71 months and was revised to a linked total elbow arthroplasty with resolution of pain and improvement in motion at last follow-up.A further patient had a well-fixed rha removed as part of open arthrolysis to address stiffness with ho.Cases where the prosthesis was removed had no evidence of infection with normal inflammatory markers.There were no postoperative infections or neurovascular complications following surgery in this series.Report 3 of 3 for the 3 cases that underwent removal.

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device model number and batch/lot number is unknown.The device was not received for evaluation.Based on the information received, the root cause could not be determined.Related reports: 3025141-2023-00135 and 3025141-2023-00136.

• Type of Device: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124
• MDR Report Key: 16826279
• MDR Text Key: 314126781
• Report Number: 3025141-2023-00137
• Device Sequence Number: 1
• Product Code: KWI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other